KOMET STEINMANN PIN SP004.228.032

GUDID E226046205K40

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: E226046205K40
• NIH Device Record Key: 6c8fb87d-1381-4773-8a46-dac845711693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOMET STEINMANN PIN
• Version Model Number: SP004.228.032.K4
• Catalog Number: SP004.228.032
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 4
• 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: false
• Expiration Date: false
• 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	14053613161449 [Primary]
GS1	84053613161448 [Unit of Use]
HIBCC	E226046205K40 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

[E226046205K40]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [KOMET STEINMANN PIN]

• E226045832K41: SP002.228.016
• E226045817K41: SP002.101.016.K4
• E226046068TW0: 804-07-338
• E226046205K40: SP004.228.032.K4
• 84053613161486: SP004.228.040.K4
• 84053613160656: SP002.228.024.K4
• 84053613160632: SP002.228.020.K4
• 84053613160489: SP002.152.020.K4
• 84053613159964: SP001.228.024.k4
• 84053613159940: SP001.228.020.K4
• 84053613159926: SP001.152.048.K4
• 84053613159865: SP001.152.032.K4
• 84053613159247: SP003.228.024.K4
• 84053613156918: SP002.152.016.K4
• 84053613155911: SP001.152.016.K4
• 84053613161240: SP001.152.020.K4
• 84053613159827: SP001.152.024.K4
• 84053613156413: SP004.152.016.K4
• 84053613160670: SP002.228.028.K4
• 84053613155812: SP001.127.016.K4
• 24053613285586: SP001.300.032.M1