Padgett Replacement Dermatome Blades Non-Sterile

Basic Information

• Brand Name: Padgett Replacement Dermatome Blades Non-Sterile
• Primary DI: 90850010779297
• Version / Model: 9.1999NS
• Catalog Number: 9.1999NS
• Company Name: Robbins Instruments Inc
• Labeler DUNS: 002182269
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-10-25
• Public Version: 3
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: be57faba-b5ec-49ec-be80-c84c280011b0

Device Description

Padgett Replacement Dermatome Blades Non-Sterile 100mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GFA	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35134	Dermatome blade, single-use	A surgical cutting device that is designed to be mounted onto a dermatome handle/handpiece (not included) and used to provide the cutting edge for the harvesting of skin grafts or excision of small skin lesions. It is available in various sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	90850010779297	GS1
Unit of Use	10850010779291	GS1

Customer Contacts

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