Ultra

GUDID 10857915007177

Ultra Endoscopic Release System

A.M. SURGICAL, INC.

Carpal tunnel 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