Sterile Hook/Triangle/Hook Blade Pack for Endotrac Endoscopic Carpal Tunnel Rele - Restore Surgical LLC

Duns Number:792932626

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Sterile Hook/Triangle/Hook Blade Pack for Endotrac Endoscopic Carpal Tunnel Rele

Version/Model Number

2057

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 29, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

e9877ee8-e5d6-4f5d-a60a-50475d04fe75

Public Version Date

January 22, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESTORE SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 192