NA - 3.5MM TI RECONSTRUCTION PLATE 10 HOLES/118MM - Synthes GmbH

Duns Number:486711679

Device Description: 3.5MM TI RECONSTRUCTION PLATE 10 HOLES/118MM

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More Product Details

Catalog Number

44500

Brand Name

NA

Version/Model Number

445.00

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

K792291,K982322

Product Code Details

Product Code

KTW

Product Code Name

APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Device Record Status

Public Device Record Key

a872d898-5383-4099-a849-85b6463acad3

Public Version Date

May 02, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNTHES GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8630
2 A medical device with a moderate to high risk that requires special controls. 16671
U Unclassified 2