AdvantageRib - Small Cannulated AO Quick-Connect Handle - SIG MEDICAL CORP.

Duns Number:080503619

Device Description: Small Cannulated AO Quick-Connect Handle

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More Product Details

Catalog Number

323.0071

Brand Name

AdvantageRib

Version/Model Number

323.0071

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

K141241

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

e4c48726-1aae-40c7-99cf-c9ea29506828

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 03, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIG MEDICAL CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 35