Integra® Padgett® Dermatomes

FDA UDI

Class I (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: Integra® Padgett® Dermatomes FDA UDI
Generic Name: Dermatome handpiece, pneumatic FDA UDI
Device Name: 12' (3.65m) Hand piece air hose FDA UDI
Model / Reference: 3539401 FDA UDI
Description: 12' (3.65m) Hand piece air hose FDA UDI

Identifiers

Catalog Number: 3539401 FDA UDI
Primary DI / UDI-DI: 10381780277439 FDA UDI
FDA Product Code: GFD FDA UDI
GMDN Term: Dermatome handpiece, pneumatic 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

Yes

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, pneumatic

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

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Also classified as Dermatome handpiece, pneumatic.

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Amalgatome SD Sterilization Tray — EXSURCO MEDICAL, INC. · Class I
Amalgatome SD 4-inch Lock Ring — EXSURCO MEDICAL, INC. · Class I
Amalgatome SD 2-inch Cutting Head — EXSURCO MEDICAL, INC. · Class I
Amalgatome SD Pneumatic Hose — EXSURCO MEDICAL, INC. · Class I
Amalgatome SD 2-inch Lock Ring — EXSURCO MEDICAL, INC. · 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

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 643bcafc-5059-4179-bcd3-c7c3e5601b90 35 fields · synced Jun 8, 2026