OsteoBridge™ - OsteoBridge IDSF Diaphysis Femoral Trial Nail 18 - Merete GmbH

Duns Number:313267265

Device Description: OsteoBridge IDSF Diaphysis Femoral Trial Nail 18 110 Connection D: 16 TiAl6V4 ELI non-ster OsteoBridge IDSF Diaphysis Femoral Trial Nail 18 110 Connection D: 16 TiAl6V4 ELI non-sterile

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More Product Details

Catalog Number

-

Brand Name

OsteoBridge™

Version/Model Number

GB92421

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

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

bd08c78c-9096-4e09-8dbd-c38dc13d0c92

Public Version Date

October 20, 2022

Public Version Number

2

DI Record Publish Date

November 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERETE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 1327
U Unclassified 13