eLIBRA® - SYNVASIVE TECHNOLOGY, INC.

Duns Number:618258974

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More Product Details

Catalog Number

20-8012-010-21

Brand Name

eLIBRA®

Version/Model Number

20-8012-010-21

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

-

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

bfc07337-3c2c-424b-baeb-f9c0643ae5c3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNVASIVE TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 251
2 A medical device with a moderate to high risk that requires special controls. 2