NA - DEPTH GAUGE FOR 2.4MM AND 2.7MM VA LOCKING SCREWS - SYNTHES (U.S.A.) LP

Duns Number:832637081

Device Description: DEPTH GAUGE FOR 2.4MM AND 2.7MM VA LOCKING SCREWS

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

SD319011

Brand Name

NA

Version/Model Number

SD319.011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2018

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

HTJ

Product Code Name

GAUGE, DEPTH

Device Record Status

Public Device Record Key

f362a9e1-5cc6-43f4-9260-38a73b565974

Public Version Date

December 07, 2018

Public Version Number

5

DI Record Publish Date

December 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNTHES (U.S.A.) LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1194
2 A medical device with a moderate to high risk that requires special controls. 4171
3 A medical device with high risk that requires premarket approval 30
U Unclassified 1