Digitex - Suture Cartridge with Needle - Polypropylene - Coloplast A/S

Duns Number:305524696

Device Description: Suture Cartridge with Needle - Polypropylene Monofiliment

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More Product Details

Catalog Number

52026

Brand Name

Digitex

Version/Model Number

52026

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

K093112,K093112

Product Code Details

Product Code

GAW

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Device Record Status

Public Device Record Key

74ad7b5c-e855-434b-9097-e9c6f23033eb

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 28, 2015

Additional Identifiers

Package DI Number

05708932440189

Quantity per Package

12

Contains DI Package

05708932615938

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Retail Box

"COLOPLAST A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 899
3 A medical device with high risk that requires premarket approval 72
U Unclassified 7