Patella Components 318-401/25

GUDID 04026575394012

3-Peg, Size 1

WALDEMAR LINK GmbH & Co. KG

Polyethylene patella prosthesis

• Primary Device ID: 04026575394012
• NIH Device Record Key: 0c2830c5-fdd0-477c-a449-df48c43b2e8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patella Components
• Version Model Number: 318-401/25
• Catalog Number: 318-401/25
• 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: true
• Serial Number: false
• 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	04026575394012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151008

FDA Product Code

• LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

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: 2021-02-05
• Device Publish Date: 2015-11-01

On-Brand Devices [Patella Components]

• 04026575394043: 3-Peg, Size 4
• 04026575394036: 3-Peg, Size 3
• 04026575394029: 3-Peg, Size 2
• 04026575394012: 3-Peg, Size 1
• 04026575198009: centric, 1-Peg
• 04026575045433: centric, 1-Peg
• 04026575045426: centric, 1-Peg