Prosthesis Head Large 99-0711/58

GUDID 04026575993345

Prosthesis Head,

WALDEMAR LINK GmbH & Co. KG

Metallic femoral head prosthesis

• Primary Device ID: 04026575993345
• NIH Device Record Key: a09584f4-4fe1-4487-9afb-e468ad804996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosthesis Head Large
• Version Model Number: 99-0711/58
• Catalog Number: 99-0711/58
• 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: false
• 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	04026575993345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953653

FDA Product Code

• JDG: Prosthesis, Hip, Femoral Component, Cemented, Metal

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: 2020-04-06
• Device Publish Date: 2015-11-01

On-Brand Devices [Prosthesis Head Large]

• 04026575993345: Prosthesis Head,
• 04026575993338: Prosthesis Head,
• 04026575993321: Prosthesis Head,
• 04026575993314: Prosthesis Head,
• 04026575993307: Prosthesis Head,
• 04026575993291: Prosthesis Head,