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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 handle FDA UDI
Device Name
Kit, Manual Dermatome, Small (3") FDA UDI
Model / Reference
3539100BTA FDA UDI
Description
Kit, Manual Dermatome, Small (3") FDA UDI

Identifiers

Catalog Number
3539100BTA FDA UDI
Primary DI / UDI-DI
10381780282327 FDA UDI
FDA Product Code
GFD FDA UDI
GMDN Term
Dermatome handle 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dermatome handle

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

Similar devices

Also classified as Dermatome handle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI bed2e340-7e77-4173-a8b4-df7100104ad3 35 fields · synced May 30, 2026