Prosthesis Head A

GUDID 04026575364671

Modular Prosthesis Head

WALDEMAR LINK GmbH & Co. KG

Ceramic femoral head prosthesis

• Primary Device ID: 04026575364671
• NIH Device Record Key: 60e72a90-fae4-4fe6-b81d-2d520642868d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosthesis Head A
• Version Model Number: 128-792/02
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575364671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161840

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2017-05-16

On-Brand Devices [Prosthesis Head A]

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• 04026575365265: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575365258: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575365241: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575365234: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575365227: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575365210: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575365203: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575359103: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575359097: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575359080: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575028283: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575028276: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575028269: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575028252: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575028245: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575028238: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575027330: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575027323: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575027316: Modular Prosthesis Head,Ceramic - Biolox forte
• 04026575416486: Modular Prosthesis Head
• 04026575416479: Modular Prosthesis Head
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• 04026575364718: Modular Prosthesis Head
• 04026575364701: Modular Prosthesis Head
• 04026575364695: Modular Prosthesis Head
• 04026575364688: Modular Prosthesis Head
• 04026575364671: Modular Prosthesis Head
• 04026575364664: Modular Prosthesis Head
• 04026575364657: Modular Prosthesis Head
• 04026575364640: Modular Prosthesis Head
• 04026575364633: Modular Prosthesis Head