Vilet II Quick™ - Vilet II Quick PGA 4/0 FS-2 [3/8C RevCt 19mm] 18" - IMPLANT DIRECT SYBRON MANUFACTURING LLC

Duns Number:868856969

Device Description: Vilet II Quick PGA 4/0 FS-2 [3/8C RevCt 19mm] 18" Undyed

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More Product Details

Catalog Number

VGQ392

Brand Name

Vilet II Quick™

Version/Model Number

VGQ392

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

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Device Record Status

Public Device Record Key

79d3dc1f-c8e9-4a61-9770-153d7a3b1f39

Public Version Date

October 17, 2022

Public Version Number

4

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

20841307130656

Quantity per Package

12

Contains DI Package

10841307130659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Chipboard Carton

"IMPLANT DIRECT SYBRON MANUFACTURING LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 1817
U Unclassified 6