GUIDE SCREW Ø3,2X48,5 STE GS903.048.032 STE

GUDID 84053613287711

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 84053613287711
• NIH Device Record Key: 1351f9c4-a324-495a-a25f-993b7889841b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUIDE SCREW Ø3,2X48,5 STE
• Version Model Number: GS903.048.032 STE.YT
• Catalog Number: GS903.048.032 STE
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 2
• 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	14053613287712 [Primary]
GS1	84053613287711 [Unit of Use]

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: 2023-12-25
• Device Publish Date: 2023-12-15

Devices Manufactured by Gebr. Brasseler GmbH & Co. KG

• E226007180R11 - KOMET Root Canal Files: 2025-06-05
• E226007181R18 - KOMET Root Canal Files: 2025-06-05
• E226007182R18 - KOMET Root Canal Files: 2025-06-05
• E226007183R18 - KOMET Root Canal Files: 2025-06-05
• E226007184R18 - KOMET Root Canal Files: 2025-06-05
• E226007185R18 - KOMET Root Canal Files: 2025-06-05
• E226007186R18 - KOMET Root Canal Files: 2025-06-05
• E226007187R18 - KOMET Root Canal Files: 2025-06-05