FORCE FIBER - Blue Braid UHMWPE Size 2 Looped HC-5 Needle S&N - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Blue Braid UHMWPE Size 2 Looped HC-5 Needle S&N

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More Product Details

Catalog Number

72205184

Brand Name

FORCE FIBER

Version/Model Number

IPN914072

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

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

37c7ea7c-135f-43b8-b0ac-a975629c382e

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

January 15, 2019

Additional Identifiers

Package DI Number

34026704637561

Quantity per Package

12

Contains DI Package

44026704637568

Package Discontinue Date

-

Package Status

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