4mm Endoscopic Release System - 4mm KNIFE & CLEAR CANNULA COMBO PACK - A.M. SURGICAL, INC.

Duns Number:160020087

Device Description: 4mm KNIFE & CLEAR CANNULA COMBO PACK

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More Product Details

Catalog Number

-

Brand Name

4mm Endoscopic Release System

Version/Model Number

9900-99

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

NBH

Product Code Name

Accessories, Arthroscopic

Device Record Status

Public Device Record Key

1553994e-367b-4f1e-92cd-a8e4dfb75e7a

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Additional Identifiers

Package DI Number

10857915007474

Quantity per Package

5

Contains DI Package

00857915007477

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"A.M. SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 12