SURGIPOINT - SUTURE - RIVERPOINT MEDICAL, LLC

Duns Number:964053560

Device Description: SUTURE

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


More Product Details

Catalog Number

-

Brand Name

SURGIPOINT

Version/Model Number

P8601

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)

-

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

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Device Record Status

Public Device Record Key

c2803c29-a178-4a74-b72b-1f1271d136eb

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

November 17, 2016

Additional Identifiers

Package DI Number

10812444026082

Quantity per Package

12

Contains DI Package

00812444026085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"RIVERPOINT MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 1369
U Unclassified 8