Reprocessed 5.5mm Great White Blade - SURETEK MEDICAL

Duns Number:785616934

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More Product Details

Catalog Number

-

Brand Name

Reprocessed 5.5mm Great White Blade

Version/Model Number

9599A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

NBH

Product Code Name

Accessories, Arthroscopic

Device Record Status

Public Device Record Key

ca47e7a6-6524-4fa9-9615-6de3abe5880c

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

December 13, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SURETEK MEDICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 616
2 A medical device with a moderate to high risk that requires special controls. 118