Fillable FDA Product Data Sheet: Medical Devices (Livingston)

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FDA Product Data Sheet: Medical Devices (Livingston)

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FDA: Medical Devices US Brokerage, 01/2016
FDA Product Data Sheet: Medical Devices
Account Number
Account Name
DUNS Number (if available)
Client Part Number*
Description of Product (as complete as possible)
Government Agency Processing Code
Tariff Number
Country of Origin**
FDA Product Code (if known)
FDA Country of Production **
Cargo Storage Status
Intended Use of Product NOTE: Conditional affirmations are required if applicable to the product being
declared. Ex: If the product require premarket clearance 510k, the PM# must be provided
* Part number as shown on Customs document to identify the product (item number, SKU, etc.)
** U.S. Customs considers the country of origin to be the country where the product last underwent a “substantial transformation” (resulting in an
increase in value.) The FDA considers the country of origin to be that of the actual manufacturer. Actual manufacturer is defined as the last party
involved in the production process.
FDA Actual Manufacturer
Address
City
State/Province
Zip/Postal Code
Country
DUNS Number (if available)
Manufacturer/Exporter Registration Numbers (Provide for all applicable)
PM#: Device premarket notification number 510K
DEV: Device foreign manufacturer registration number
LST: Device listing number for product
IDE: Investigational device exemption number
KIT: Device imported kit of finished device
DFE: Device foreign exporter registration number
PMA: Device premarket approval number
DDM: Domestic device manufacture
CDP: Device component (If component, no registration #
required)
Other
FDA Shipper (As shown on Customs document, BOL or airway bill)
Address
City
State/Province
Zip/Postal Code
Country
DUNS Number (if available)
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FDA Product Data Sheet: Medical Devices (Livingston)

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Completed 23 September 2021

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