RetroArc - RetroArc Needles and Handle - ENDO PHARMACEUTICALS INC.

Duns Number:178074951

Device Description: RetroArc Needles and Handle

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More Product Details

Catalog Number

1006346

Brand Name

RetroArc

Version/Model Number

1006346

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2016

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

OTN

Product Code Name

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Device Record Status

Public Device Record Key

eb80a363-042d-4eab-8a6a-8257db74d219

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENDO PHARMACEUTICALS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 15
3 A medical device with high risk that requires premarket approval 2