Integra® Padgett® Dermatomes

Basic Information

• Brand Name: Integra® Padgett® Dermatomes
• Primary DI: 10381780282310
• Version / Model: 35391005TA
• Catalog Number: 35391005TA
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Labeler DUNS: 963856096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-23
• Public Version: 3
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: 1594d097-4b23-4418-992d-77d386c4b214

Device Description

Kit, Manual Dermatome, large (5")

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GFD	DERMATOME	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38797	Dermatome handle	A hand-held manual surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade (not included). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M24835391005TA1	HIBCC
Primary	10381780282310	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]