ForceFlex - Suture - RIVERPOINT MEDICAL, LLC

Duns Number:964053560

Device Description: Suture

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More Product Details

Catalog Number

-

Brand Name

ForceFlex

Version/Model Number

SS641

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

PTX

Product Code Name

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

Device Record Status

Public Device Record Key

e87d46f9-32b2-4cec-ba2e-1947b42adda0

Public Version Date

July 07, 2022

Public Version Number

1

DI Record Publish Date

June 29, 2022

Additional Identifiers

Package DI Number

10810020085461

Quantity per Package

12

Contains DI Package

00810020085464

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