NA - LARGE EX-FIX 11MM CRBN FBR ROD 450MM / - Synthes GmbH

Duns Number:486711679

Device Description: LARGE EX-FIX 11MM CRBN FBR ROD 450MM / MR-CONDITIONAL

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More Product Details

Catalog Number

39488

Brand Name

NA

Version/Model Number

394.88

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K033158,K950384,K122455,K082650

Product Code Details

Product Code

KTT

Product Code Name

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

Device Record Status

Public Device Record Key

c8cd2fe3-2475-4046-9aca-86a2ddb7d9a4

Public Version Date

May 02, 2022

Public Version Number

5

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