TITAN™ DOUBLE WIRE - MONOFILAMENT 316 LVMSTAINLESS STEEL SUTURE,CCS1 - JACE MEDICAL, LLC

Duns Number:063554875

Device Description: MONOFILAMENT 316 LVMSTAINLESS STEEL SUTURE,CCS1 NEEDLE, 49MM, USP 6, 14", 3 PK

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

TITAN™ DOUBLE WIRE

Version/Model Number

132.641.23

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

PTX

Product Code Name

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

Device Record Status

Public Device Record Key

50caccad-c0c1-460a-8d4c-b74c26c9c7a8

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

October 10, 2021

Additional Identifiers

Package DI Number

00853190008161

Quantity per Package

12

Contains DI Package

00853190008994

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"JACE MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 125