K2M Fenestrated Tap System SP-4029-06

GUDID 10888857461338

Tap, Fenestrated, Size Ø8.5

K2M, INC.

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• Primary Device ID: 10888857461338
• NIH Device Record Key: f0ae3554-4b72-4a66-b648-70dbfb56e1f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2M Fenestrated Tap System
• Version Model Number: SP-4029-06
• Catalog Number: SP-4029-06
• Company DUNS: 146060863
• Company Name: K2M, INC.
• Device Count: 1
• 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: 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

Customer Support Contacts

• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com

Device Dimensions

• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857461338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152872

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

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

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

[10888857461338]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-03
• Device Publish Date: 2020-01-24

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