(2) K-Wire Smooth Ø1,4x89mm ED-10986

GUDID 84053613289531

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 84053613289531
• NIH Device Record Key: 27efc57d-206e-479b-8e4f-f6b28af2fc6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: (2) K-Wire Smooth Ø1,4x89mm
• Version Model Number: ED-10986
• Catalog Number: ED-10986
• 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	14053613289532 [Primary]
GS1	84053613289531 [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: 2024-03-07
• Device Publish Date: 2024-02-28

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