REMA Shaver Blades

Basic Information

• Brand Name: REMA Shaver Blades
• Primary DI: 04059223160073
• Version / Model: 15-61530
• Catalog Number: 15-61530
• Company Name: DEWIMED Medizintechnik GmbH
• Labeler DUNS: 343472288
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-02-27
• Public Version: 1
• Public Version Date: 2025-03-07
• Public Version Status: New
• Public Device Record Key: a9ffbe65-63c1-41c4-9fc1-7c9bc914e714

Device Description

FULL-RADIUS RESECTOR Ø 5,5 MM

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRX	Arthroscope	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38654	Arthroscopic shaver system blade, reusable	A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	14035282341780	GS1
Primary	04059223160073	GS1