Prosthesis Head B 198-824/02

GUDID 04026575193714

WALDEMAR LINK GmbH & Co. KG

Metallic femoral head prosthesis

• Primary Device ID: 04026575193714
• NIH Device Record Key: f313ca87-7d1d-4f25-b835-92a278582e3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosthesis Head B
• Version Model Number: 198-824/02
• Catalog Number: 198-824/02
• 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: 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	04026575193714 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-01
• Device Publish Date: 2022-03-24

On-Brand Devices [Prosthesis Head B]

• 04026575404728: Modular Prosthesis Head,CoCrMo
• 04026575404711: Modular Prosthesis Head,CoCrMo
• 04026575404704: Modular Prosthesis Head,CoCrMo
• 04026575404384: Modular Prosthesis Head,CoCrMo
• 04026575365197: Modular Prosthesis Head,CoCrMo
• 04026575365180: Modular Prosthesis Head,CoCrMo
• 04026575365173: Modular Prosthesis Head,CoCrMo
• 04026575365166: Modular Prosthesis Head,CoCrMo
• 04026575365159: Modular Prosthesis Head,CoCrMo
• 04026575365142: Modular Prosthesis Head,CoCrMo
• 04026575365135: Modular Prosthesis Head,CoCrMo
• 04026575365128: Modular Prosthesis Head,CoCrMo
• 04026575365111: Modular Prosthesis Head,CoCrMo
• 04026575365104: Modular Prosthesis Head,CoCrMo
• 04026575365098: Modular Prosthesis Head,CoCrMo
• 04026575365081: Modular Prosthesis Head,CoCrMo
• 04026575365074: Modular Prosthesis Head,CoCrMo
• 04026575365067: Modular Prosthesis Head,CoCrMo
• 04026575365050: 128-822/01
• 04026575364763: Modular Prosthesis Head,CoCrMo
• 04026575364749: Modular Prosthesis Head,CoCrMo
• 04026575280766: Modular Prosthesis Head,CoCrMo
• 04026575280759: Modular Prosthesis Head,CoCrMo
• 04026575207510: Modular Prosthesis Head,CoCrMo
• 04026575207503: Modular Prosthesis Head,CoCrMo
• 04026575028221: Modular Prosthesis Head,CoCrMo
• 04026575028214: Modular Prosthesis Head,CoCrMo
• 04026575028207: Modular Prosthesis Head,CoCrMo
• 04026575028191: Modular Prosthesis Head,CoCrMo
• 04026575028184: Modular Prosthesis Head,CoCrMo
• 04026575028177: Modular Prosthesis Head,CoCrMo
• 04026575028160: Modular Prosthesis Head,CoCrMo
• 04026575028153: Modular Prosthesis Head,CoCrMo
• 04026575028146: Modular Prosthesis Head,CoCrMo
• 04026575028122: Modular Prosthesis Head,CoCrMo
• 04026575028115: Modular Prosthesis Head,CoCrMo
• 04026575028108: Modular Prosthesis Head,CoCrMo
• 04026575027309: Modular Prosthesis Head,CoCrMo
• 04026575027262: Modular Prosthesis Head,CoCrMo
• 04026575253463: Modular Prosthesis Head,CoCrMo
• 04026575193288: Modular Prosthesis Head,CoCrMo
• 04026575193271: Modular Prosthesis Head,CoCrMo
• 04026575193264: Modular Prosthesis Head,CoCrMo
• 04026575193509: 198-824/01
• 04026575193493: 198-822/02
• 04026575193486: 198-822/01
• 04026575193868: 198-836/04
• 04026575193851: 198-836/03
• 04026575193844: 198-836/02
• 04026575193837: 198-836/01