VICRYL RAPIDE - Undyed Braided (Polyglactin 910), Synthetic - Johnson & Johnson International Inc.

Duns Number:372587696

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

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More Product Details

Catalog Number

VR2218

Brand Name

VICRYL RAPIDE

Version/Model Number

VR2218

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

K033746,K033746

Product Code Details

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Device Record Status

Public Device Record Key

06a8cdfd-5bf2-452a-925a-cc2dc988a3a4

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

30705031225132

Quantity per Package

12

Contains DI Package

10705031225138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"JOHNSON & JOHNSON INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 84