ZIMMER - HAND HELD RETRACTOR, 23 X 70 MM, SMALL LIP, BLUE - TEDAN SURGICAL INNOVATIONS, L.L.C.

Duns Number:791619393

Device Description: HAND HELD RETRACTOR, 23 X 70 MM, SMALL LIP, BLUE

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More Product Details

Catalog Number

-

Brand Name

ZIMMER

Version/Model Number

ZCS-0223

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

8df433b2-fdb1-49d2-a99b-674d0ca8b0c1

Public Version Date

January 17, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEDAN SURGICAL INNOVATIONS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2398
2 A medical device with a moderate to high risk that requires special controls. 51