Coated VICRYL - Undyed Braided (Polyglactin 910), Synthetic - ETHICON, LLC

Duns Number:079402290

Device Description: Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture

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More Product Details

Catalog Number

J823H

Brand Name

Coated VICRYL

Version/Model Number

J823H

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

K022269,K183183,K022269,K183183

Product Code Details

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Device Record Status

Public Device Record Key

1536b97a-db38-4101-8d91-3f23cba999d3

Public Version Date

February 05, 2021

Public Version Number

7

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

20705031000282

Quantity per Package

36

Contains DI Package

10705031000285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"ETHICON, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 1028
3 A medical device with high risk that requires premarket approval 15
U Unclassified 1