Secure IM Nail

GUDID 00857915007064

One 45mm x 1.6mm IM Nail

A.M. SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00857915007064
• NIH Device Record Key: 704b7407-0db4-4efd-81f2-d3849ff90b35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Secure IM Nail
• Version Model Number: 8960-45
• Company DUNS: 160020087
• Company Name: A.M. SURGICAL, 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: true
• 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: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com
• Phone: 631-979-9777
• Email: service@amsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857915007064 [Primary]
GS1	10857915007061 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180087

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-10-12
• Device Publish Date: 2018-07-16

On-Brand Devices [Secure IM Nail]

• 00857915007125: IM Nail Combo Kit
• 00857915007095: One 60mm x 1.6mm IM Nail
• 00857915007088: One 55mm x 1.6mm IM Nail
• 00857915007071: One 50mm x 1.6mm IM Nail
• 00857915007064: One 45mm x 1.6mm IM Nail
• 00857915007057: One 40mm x 1.6mm IM Nail
• 00857915007385: One 70mm x 1.2mm IM Nail
• 00857915007378: One 65mm x 1.2mm IM Nail
• 00857915007361: One 60mm x 1.2mm IM Nail
• 00857915007354: One 55mm x 1.2mm IM Nail
• 00857915007347: One 50mm x 1.2mm IM Nail
• 00857915007330: One 45mm x 1.2mm IM Nail
• 00857915007323: One 40mm x 1.2mm IM Nail
• 00857915007316: One 35mm x 1.2mm IM Nail
• 00857915007309: One 30mm x 1.2mm IM Nail
• 00857915007293: One 70mm x 1.6mm IM Nail
• 00857915007286: One 65mm x 1.6mm IM Nail