ACE

Basic Information

• Brand Name: ACE
• Primary DI: 00614950025152
• Version / Model: 6500007
• Catalog Number: 6500007
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Labeler DUNS: 042763706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-24
• Public Version: 2
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: 9af7b75e-c652-4008-8ff9-159a7c3de42e

Device Description

REPLACEMENT SHOE 1.25MM X 9MM WIDE

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: No
• 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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12253	Skin grafting knife	A hand-held, one-piece, manual surgical instrument designed to cut donor-site skin strips intended for grafting. It has a knife-like design with a flat broad blade and a sharp cutting edge; it is usually made of stainless steel. This device may reflect old technology. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614950025152	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1.25	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No special storage conditions required