NA - UNIVERSAL NAIL INSERTION SET GRAPHIC CASE LARGE - SYNTHES (U.S.A.) LP

Duns Number:832637081

Device Description: UNIVERSAL NAIL INSERTION SET GRAPHIC CASE LARGE TRAY

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More Product Details

Catalog Number

30568

Brand Name

NA

Version/Model Number

305.68

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 28, 2020

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

869476b8-fcb9-4e86-a6bf-e98036754b3c

Public Version Date

June 29, 2020

Public Version Number

4

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