TiMESH - Ti-Mesh 4" X 6" Light 35 g/m² - pfm medical titanium gmbh

Duns Number:344675942

Device Description: Ti-Mesh 4" X 6" Light 35 g/m²

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More Product Details

Catalog Number

-

Brand Name

TiMESH

Version/Model Number

6000138

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)

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

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

2bb94765-373d-4868-a7b7-3cc6791015af

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

December 09, 2019

Additional Identifiers

Package DI Number

04042301097576

Quantity per Package

3

Contains DI Package

04042301097569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"PFM MEDICAL TITANIUM GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12