LINK Instruments - Impactors, extractors and insertion

Basic Information

• Brand Name: LINK Instruments - Impactors, extractors and insertion
• Primary DI: 04026575034413
• Version / Model: 130-849
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Labeler DUNS: 315675488
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-19
• Public Version: 1
• Public Version Date: 2022-12-27
• Public Version Status: New
• Public Device Record Key: 09fefc64-c41e-44f2-9ec7-e9fbe5a9332b

Device Description

Hip prosthesis socket pusher - Screw-In Acetabular Cup Systems Type K and Type V

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: Yes
• 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
HWA	IMPACTOR	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32878	Hip prosthesis socket pusher	A hand-held manual surgical instrument with a grip designed to hold an acetabular cup or shell at the distal end. It is rod-like in shape and used to force the acetabular component of a total hip prosthesis into the proper position in the acetabular vault of the pelvis. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04026575034413	GS1