POWERTEX - SUTURE - RIVERPOINT MEDICAL, LLC

Duns Number:964053560

Device Description: SUTURE

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More Product Details

Catalog Number

-

Brand Name

POWERTEX

Version/Model Number

SUTRPBLAG1

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

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Device Record Status

Public Device Record Key

708ff2d0-bd4e-4592-b02c-cbd12c63218c

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

May 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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