KOMET K-Wire KW001.152.011

GUDID 84053613155874

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone wire

• Primary Device ID: 84053613155874
• NIH Device Record Key: 2d51aa7c-cf9c-4822-b6e0-2baa7b4e6818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOMET K-Wire
• Version Model Number: KW001.152.011.K4
• Catalog Number: KW001.152.011
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 10
• 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	14053613155875 [Primary]
GS1	84053613155874 [Unit of Use]

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

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

[84053613155874]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [KOMET K-Wire]

• E226045831K41: KW002.228.014
• E226045816K41: KW002.101.014.K4
• E226045815K41: KW002.101.011
• 84053613156970: KW002.228.011.K4
• 84053613156895: KW002.152.014.K4
• 84053613156871: KW002.152.011.K4
• 84053613156857: KW002.152.009.K4
• 84053613156833: KW002.152.007.K4
• 84053613156659: KW002.101.009.K4
• 84053613155973: KW001.228.011.K4
• 84053613155898: KW001.152.014.K4
• 84053613155874: KW001.152.011.K4
• 84053613155850: KW001.152.009.K4
• 84053613155836: KW001.152.007.K4
• 84053613157434: KW003.228.009.K4
• 84053613156390: KW004.152.014.K4
• 84053613156376: KW004.152.011.K4
• 84053613156352: KW004.152.009.K4
• 84053613156338: KW004.152.007.K4
• 84053613157151: KW003.101.011.K4
• 84053613156956: KW002.228.009.K4
• 84053613156475: KW004.228.011.K4
• 84053613156451: KW004.228.009.K4