Torgue Limiter, AO Connection - JACE MEDICAL, LLC

Duns Number:063554875

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More Product Details

Catalog Number

-

Brand Name

Torgue Limiter, AO Connection

Version/Model Number

201.047.00

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)

-

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

HWR

Product Code Name

Driver, Prosthesis

Device Record Status

Public Device Record Key

a7e7d821-f965-4b51-aa23-efe82ad85b6b

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

January 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JACE MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 125