VERSALOK ORTHOCORD - VERSALOK ANCHOR w/ORTHOCORD PEEK & Titanium - DEPUY MITEK, LLC

Duns Number:190572854

Device Description: VERSALOK ANCHOR w/ORTHOCORD PEEK & Titanium Anchor (1) Violet (1) Blue Strand, Size 2 (5 m VERSALOK ANCHOR w/ORTHOCORD PEEK & Titanium Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm)

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More Product Details

Catalog Number

210808

Brand Name

VERSALOK ORTHOCORD

Version/Model Number

210808

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

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Device Record Status

Public Device Record Key

8a41d7ca-1a8d-4555-9062-5a09aac64d06

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEPUY MITEK, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 560
2 A medical device with a moderate to high risk that requires special controls. 479