SteriTatt Original Black Cartridge - FLOW X RAY CORPORATION

Duns Number:010016319

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More Product Details

Catalog Number

-

Brand Name

SteriTatt Original Black Cartridge

Version/Model Number

90001

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

Yes

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

FZZ

Product Code Name

Marker, Skin

Device Record Status

Public Device Record Key

5f7994ec-f6e9-4791-b479-e05da423c84b

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLOW X RAY CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3215