KOMET STEINMAN PIN SP003.228.024 STE

GUDID 24053613285043

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 24053613285043
• NIH Device Record Key: 3709eccf-2c4d-4410-ab8b-f94d1fc0eb66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOMET STEINMAN PIN
• Version Model Number: SP003.228.024YT
• Catalog Number: SP003.228.024 STE
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler 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: 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	14053613285046 [Primary]
GS1	24053613285043 [Package]; Contains: 14053613285046; Package: [1 Units]; In Commercial Distribution

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: 2021-12-29
• Device Publish Date: 2021-12-21

On-Brand Devices [KOMET STEINMAN PIN]

• 84053613159803: SP001.152.020.K4
• 24053613285043: SP003.228.024YT