Reprocessed 2.9mm Tricut Blade, Rotatable - Reprocessed 2.9mm Tricut Blade, Rotatable, - SURETEK MEDICAL

Duns Number:785616934

Device Description: Reprocessed 2.9mm Tricut Blade, Rotatable, without Tubing

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More Product Details

Catalog Number

-

Brand Name

Reprocessed 2.9mm Tricut Blade, Rotatable

Version/Model Number

18-82904HR

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

9b306564-341f-4e68-b080-c9ba6e835e35

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

May 06, 2019

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