Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660094041
• Version / Model: Watson skin graft knife
• Catalog Number: 39-945
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-04
• Public Version: 2
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: c55a9cb1-5c9f-496c-8cae-ffdc235f6496

Device Description

Watson skin graft knife, 12 1/2'', adjustable from 0.1mm to 1.0mm cut depth, flat handle

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: No
• 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
KTG	KNIFE, ENT	Ear, Nose, Throat	874.4420	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
Primary	00190660094041	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]