ACE

Basic Information

• Brand Name: ACE
• Primary DI: 00614950000111
• Version / Model: 0034210
• Catalog Number: 0034210
• 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: 2015-10-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8e310649-ca6a-4932-9c99-d7e512e8a3b7

Device Description

AUTOGRAFTER ACE AUTOCLAVABLE NON-STERILE W/L

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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: No

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
44874	Orthopaedic graft guide	A device used to protect a graft during delivery to the site of implantation. The graft is inserted into the device, which allows introduction and manoeuvring into difficult sites [e.g., during delivery into the tibial and femoral tunnel during anterior cruciate ligament (ACL) reconstruction surgery]. It is typically tubular-shaped, made of sturdy materials (e.g., stainless steel, hard plastic) and comes in varying 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	00614950000111	GS1

Customer Contacts

• Phone: [phone] ext. 214
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	4	Inch
Width	1.5	Inch