DEKNATEL - SLK BK BR 3-0 18"X3 - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: SLK BK BR 3-0 18"X3

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More Product Details

Catalog Number

X-1762

Brand Name

DEKNATEL

Version/Model Number

IPN026760

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

GAP

Product Code Name

SUTURE, NONABSORBABLE, SILK

Device Record Status

Public Device Record Key

218e1c52-9250-48b7-9ddd-bc30e5a12955

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

March 24, 2017

Additional Identifiers

Package DI Number

34026704592716

Quantity per Package

36

Contains DI Package

14026704592712

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