K-Wire Threaded Ø1,4x89mm ED-10989

GUDID 84053613287155

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 84053613287155
• NIH Device Record Key: edc67b2e-9972-4f44-a583-4e27becb888c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Wire Threaded Ø1,4x89mm
• Version Model Number: ED-10989
• Catalog Number: ED-10989
• 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	14053613287156 [Primary]
GS1	84053613287155 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• HTY: Pin, Fixation, Smooth

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

• 24053613265496 - Steinmann Pin: 2026-03-30
• 24053613296209 - Bur, tapered, round shank: 2026-03-30
• 24053613295929 - Bur, Round, round shank: 2026-03-19
• 24053613295936 - Bur, Round, round shank: 2026-03-19
• 24053613296131 - Bur, Round, round shank: 2026-03-19
• 24053613296193 - Bur, tapered, round shank: 2026-03-19
• 24053613296803 - Bur, Round, round shank: 2026-03-19
• 24053613297121 - Bur, cylindrical, round shank: 2026-03-19