Integra® Padgett®

FDA UDI

Class I (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: Integra® Padgett® FDA UDI
Generic Name: Dermatome handpiece, electrically-powered FDA UDI
Device Name: Integra® Padgett® Dermatomes Hand piece, B Model FDA UDI
Model / Reference: DP0001 FDA UDI
Description: Integra® Padgett® Dermatomes Hand piece, B Model FDA UDI

Identifiers

Catalog Number: DP0001 FDA UDI
Primary DI / UDI-DI: 10381780277767 FDA UDI
FDA Product Code: GFD FDA UDI
GMDN Term: Dermatome handpiece, electrically-powered FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dermatome handpiece, electrically-powered

Integra® Padgett® by Integra Lifesciences Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatome handpiece, electrically-powered.

Tissue Bank Dermatome — Zimmer Orthopaedic Surgical Products · Class I
CELLUTOME™ — KCI USA, INC. · Class I
Dermatome — Zimmer Orthopaedic Surgical Products · Class I
Dermatome — Zimmer Orthopaedic Surgical Products · Class I
De Soutter Medical — De Soutter Medical, Ltd. · Class I
Dermatome 100mm — Nouvag AG · Class I
EPITECH — TARA MEDICAL DEVICES LLC · Class I
Tissue Bank Dermatome — Zimmer Orthopaedic Surgical Products · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 7d2460dd-bef6-4231-a2c4-bb49c9cce51e 35 fields · synced May 30, 2026