Preparing the required information (applies to unique lines only)

Importer's Entry Notice

list of examples for ACE entries 12-15-2016

Preparing the required information (applies to unique lines only)

OMB: 0910-0046

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The following are examples of Typical Data sets Filers are required to submit to FDA in ACE

for a Biological Product

Data submitted by Filer:

Intended Use Code:

080.000

CBP required: Product Description

Rubella vaccine

Product code:

57CH-99

Country of Production

DE

CBP required Manufacturer (name/address)

Baxter AG, Industriestasse 72, Munich, Germany

CBP required Shipper (name/address):

Baxter AG, Industriestasse 72, Munich Germany

CBP required Consignee (name/address):

Baxter Healthcare Corp. Deerfield, IL 60015

Importer (name/Contact):

Earl, Adolph David 1-800-423-2090 ADEARL@Baxter.com

Specific product data:

BLN 1026 STN 10656



for a Drug Product

Data submitted by Filer:

Intended Use Code:

180.009

CBP required: Product Description

Acetaminophen

Product code:

60LIC01

Country of Production

DE

CBP required Manufacturer (name/address)

Baxter AG, Industriestasse 72, Munich, Germany

CBP required Shipper (name/address):

Baxter AG, Industriestasse 72, Munich Germany

CBP required Consignee (name/address):

Baxter Healthcare Corp. Deerfield, IL 60015

Importer (name/Contact):

Earl, Adolph David 1-800-423-2090 ADEARL@Baxter.com

Specific product data:

IND 058907



for a Medical Device Product

Data submitted by Filer:

Intended Use Code:

081.001

CBP required: Product Description

Myocardial Pacing Lead

Product code:

74N--HW

Country of Production

DE

CBP required Manufacturer (name/address)

Richard Wolf GMBH, Wurttemberg, Germany

CBP required Shipper (name/address):

Greybatch Medical, 2300 Berkshire Lane Minneapolis, MN 55441

CBP required Consignee (name/address):

Greybatch Medical, 2300 Berkshire Lane Minneapolis, MN 55441

Importer (name/Contact):

Earl, Adolph David 1-800-423-2090 ADEARL@Greybatch.com

Specific product data:

DEV 1234567 DFE 2345678 LST E12345



for a Cosmetic Product

Data submitted by Filer:

Intended Use Code:

UNK

CBP required: Product Description

Eye Shadow

Product code:

53CD-03

Country of Production

CA

CBP required Manufacturer (name/address)

Bare Escentualse, 2960 Kingsway Dr. Ont, CA N2C 1X1

CBP required Shipper (name/address):

Bare Escentualse, 2960 Kingsway Dr. Ont, CA N2C 1X1

CBP required Consignee (name/address):

Bare Escentualse, 71 Stevens Dr, SanFrancisco, CA 94105

Importer (name/Contact):

Earl, Adolph David 1-800-423-2090 ADEARL@BareMineral.com

Specific product data:

n/a



for a Tobacco Product

Data submitted by Filer:

Intended Use Code:

UNK

CBP required: Product Description

Cigar tobacco leaves

Product code:

98BAA01

Country of Production

MX

CBP required Manufacturer (name/address)

Excaliber Tobacco, Mexico City, MX 11122

CBP required Shipper (name/address):

General Tobacco Co, 230 Berkshire Ln, San Francisco CA 94105

CBP required Consignee (name/address):

General Tobacco Co, 230 Berkshire Ln, San Francisco CA 94105

Importer (name/Contact):

Earl, Adolph David 1-800-423-2090 ADEARL@GenTobacco.com

Specific product data:

n/a



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AuthorOEIO/DCS
Last Modified ByJonna Capezzuto
File Modified2016-12-15
File Created2016-12-15

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