FORCE FIBER - White/Green Co-braid Size 2 36" Pivot - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: White/Green Co-braid Size 2 36" Pivot

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More Product Details

Catalog Number

CAT01585

Brand Name

FORCE FIBER

Version/Model Number

IPN000888

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"

Yes

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

-

Product Code Details

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Device Record Status

Public Device Record Key

08e4ded0-3109-45c0-9b01-7f2d4dd97c3f

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

14026704604729

Quantity per Package

12

Contains DI Package

34026704604723

Package Discontinue Date

January 15, 2019

Package Status

Not in Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26