PDS - Violet Monofilament (Polydioxanone), Synthetic - ETHICON, LLC

Duns Number:079402290

Device Description: Violet Monofilament (Polydioxanone), Synthetic Absorbable Surgical Suture

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More Product Details

Catalog Number

Z1935T

Brand Name

PDS

Version/Model Number

Z1935T

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

K183183,K183183

Product Code Details

Product Code

NEW

Product Code Name

Suture, surgical, absorbable, polydioxanone

Device Record Status

Public Device Record Key

7b82d7fb-4914-4b4c-a50e-aa903f07905e

Public Version Date

March 01, 2021

Public Version Number

1

DI Record Publish Date

February 19, 2021

Additional Identifiers

Package DI Number

30705031461714

Quantity per Package

24

Contains DI Package

10705031461710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"ETHICON, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 1028
3 A medical device with high risk that requires premarket approval 15
U Unclassified 1