Guide Screw Set - APOLLOKNEE PIN PACK TKR.IN.1316

GUDID 14053613289297

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 14053613289297
• NIH Device Record Key: 85bd1f72-0e95-4b0e-b117-fb993a7b007c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Screw Set - APOLLOKNEE PIN PACK
• Version Model Number: TKR.IN.1316
• Catalog Number: TKR.IN.1316
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• 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: 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	14053613289297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2024-09-06
• Device Publish Date: 2024-08-29

On-Brand Devices [Guide Screw Set - APOLLOKNEE PIN PACK]

• 14053613289303: TKR.IN.1317
• 14053613289297: TKR.IN.1316
• 14053613289280: TKR.IN.1315
• 14053613289266: TKR.IN.1313
• 14053613289273: TKR.IN.1314