Insertion Package - Tubing Passer - AMERICAN MEDICAL SYSTEMS, INC.

Duns Number:125111448

Device Description: Tubing Passer

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More Product Details

Catalog Number

-

Brand Name

Insertion Package

Version/Model Number

72100005

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

-

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

EZY

Product Code Name

Device, Incontinence, Mechanical/Hydraulic

Device Record Status

Public Device Record Key

26a1c585-a80c-4bb6-9538-e6fe23a94322

Public Version Date

February 13, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2014

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