AdVance - Needle Passers - AMERICAN MEDICAL SYSTEMS, INC.

Duns Number:125111448

Device Description: Needle Passers

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More Product Details

Catalog Number

-

Brand Name

AdVance

Version/Model Number

84414379

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2020

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

OTM

Product Code Name

Mesh, Surgical, For Stress Urinary Incontinence, Male

Device Record Status

Public Device Record Key

44652516-60cb-4d40-90dc-56d65322d889

Public Version Date

June 15, 2022

Public Version Number

7

DI Record Publish Date

July 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 8
3 A medical device with high risk that requires premarket approval 139