Ace Medical Company

Basic Information

• Brand Name: Ace Medical Company
• Primary DI: 00840217909815
• Version / Model: 03-280-101
• Catalog Number: 03-280-101
• Company Name: Ebner Medical, LLC
• Labeler DUNS: 106135367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-14
• Public Version: 1
• Public Version Date: 2025-08-22
• Public Version Status: New
• Public Device Record Key: 79953416-4f4b-43c1-aa83-f4224d447bab

Device Description

Cloward Style Blade Retr,13mm x 75mm blde,7 1/2", no lip

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45182	Self-retaining surgical retractor, reusable	A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840217909815	GS1