USS - 10.0MM TI DUAL CORE USS 50MM SIDE-OPENING SCREW - Synthes GmbH

Duns Number:486711679

Device Description: 10.0MM TI DUAL CORE USS 50MM SIDE-OPENING SCREW F/6.0MM ROD

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More Product Details

Catalog Number

04602150

Brand Name

USS

Version/Model Number

04.602.150

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

K003061

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

9b9bc272-7ced-487f-b667-73a592b5ce5b

Public Version Date

July 22, 2022

Public Version Number

1

DI Record Publish Date

July 14, 2022

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