GORE-TEX Suture - CV-7 SUTURE 30" PT-09 DA 3 DZ - W. L. Gore & Associates, Inc.

Duns Number:967358115

Device Description: CV-7 SUTURE 30" PT-09 DA 3 DZ

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More Product Details

Catalog Number

7M04B

Brand Name

GORE-TEX Suture

Version/Model Number

7M04B

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

P820083,P820083

Product Code Details

Product Code

GAW

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Device Record Status

Public Device Record Key

78b48268-f7aa-4410-a176-40e06ff63496

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

February 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"W. L. GORE & ASSOCIATES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 561
3 A medical device with high risk that requires premarket approval 623