2.7 mm Endoscopic Release System

GUDID 10857915007511

2.7 mm KNIFE & CLEAR CANNULA COMBO PACK

A.M. SURGICAL, INC.

Carpal tunnel release instrument
Primary Device ID10857915007511
NIH Device Record Keyd2303ec8-44a3-4a73-bb50-9a39f7a3320f
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.7 mm Endoscopic Release System
Version Model Number4500-99
Company DUNS160020087
Company NameA.M. SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com
Phone6319799777
Emailservice@amsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857915007514 [Primary]
GS110857915007511 [Package]
Contains: 00857915007514
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

NBHAccessories, Arthroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-23
Device Publish Date2020-01-15

Devices Manufactured by A.M. SURGICAL, INC.

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10857915007214 - Secure Screw 50mm2021-02-17 Secure Screw 50mm
00857915007255 - Secure Screw 55mm2021-02-17 Secure Screw 55mm
10857915007238 - Secure Screw 60mm2021-02-17 Secure Screw 60mm
00857915007262 - Secure Screw Starter Pack 2021-02-17 Secure Screw Starter Pack
10857915007566 - Secure Screw 35mm2021-02-17 Secure Screw 35mm
00857915007606 - PARA CPX2021-01-19 PARA Cross Pin External Fixation Frame and One Tightening Tool

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