Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 5/0 - Extra Cutting tip - - OMNIA SRL

Duns Number:447696675

Device Description: PTFE Suture 75 cm - 5/0 - Extra Cutting tip - 12 mm Needle 3/8 - Extra Reverse Cutting

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More Product Details

Catalog Number

-

Brand Name

Sterile PTFE Surgical Suture

Version/Model Number

32.Z3252.00

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"

-

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

NBY

Product Code Name

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Device Record Status

Public Device Record Key

60f6c0e1-d651-4958-bced-9be6828077eb

Public Version Date

December 21, 2018

Public Version Number

3

DI Record Publish Date

March 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OMNIA SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 28