KIM (Knotless Incontinence Mesh) - DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL

Duns Number:513271056

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More Product Details

Catalog Number

-

Brand Name

KIM (Knotless Incontinence Mesh)

Version/Model Number

KIM01/OID5

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)

-

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

933cc0d8-d313-4bd8-bf0f-8a807a501cb7

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13