DEKNATEL - RC SLK BK BR 1 24"X12 - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: RC SLK BK BR 1 24"X12

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More Product Details

Catalog Number

S-926

Brand Name

DEKNATEL

Version/Model Number

IPN025494

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

GAP

Product Code Name

SUTURE, NONABSORBABLE, SILK

Device Record Status

Public Device Record Key

d2fc4862-2043-46fc-a543-638a84ef647b

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

24026704424348

Quantity per Package

12

Contains DI Package

04026704424344

Package Discontinue Date

May 08, 2017

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