PDM - SUTURE - RIVERPOINT MEDICAL, LLC

Duns Number:964053560

Device Description: SUTURE

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More Product Details

Catalog Number

-

Brand Name

PDM

Version/Model Number

D969

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

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Device Record Status

Public Device Record Key

d5cf12af-d01b-4d94-ac86-22e59a920ca4

Public Version Date

October 17, 2022

Public Version Number

7

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

10812444021094

Quantity per Package

12

Contains DI Package

00812444021097

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