Ultra

GUDID 10857915007177

Ultra Endoscopic Release System

A.M. SURGICAL, INC.

Carpal tunnel release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument

• Primary Device ID: 10857915007177
• NIH Device Record Key: 02fbb55f-ea5d-40f6-ae9f-587e09beb9e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra
• Version Model Number: 2400
• Company DUNS: 160020087
• Company Name: A.M. SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857915007170 [Primary]
GS1	10857915007177 [Package]; Contains: 00857915007170; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• NBH: Accessories, Arthroscopic

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: 2018-11-19
• Device Publish Date: 2018-10-18

Devices Manufactured by A.M. SURGICAL, INC.

• 10857915007191 - Secure Screw 40mm: 2021-02-17 Secure Screw 40mm
• 00857915007248 - Secure Screw 45mm: 2021-02-17 Secure Screw 45mm
• 10857915007214 - Secure Screw 50mm: 2021-02-17 Secure Screw 50mm
• 00857915007255 - Secure Screw 55mm: 2021-02-17 Secure Screw 55mm
• 10857915007238 - Secure Screw 60mm: 2021-02-17 Secure Screw 60mm
• 00857915007262 - Secure Screw Starter Pack: 2021-02-17 Secure Screw Starter Pack
• 10857915007566 - Secure Screw 35mm: 2021-02-17 Secure Screw 35mm
• 00857915007606 - PARA CPX: 2021-01-19 PARA Cross Pin External Fixation Frame and One Tightening Tool