Tissu-Trans Syringe Fill - Syringes for Collection, Decantation and - SHIPPERT MEDICAL TECHNOLOGIES, INC

Duns Number:051437143

Device Description: Syringes for Collection, Decantation and Re-injection of Autologous Tissue.

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More Product Details

Catalog Number

3-TT-SFL60x3

Brand Name

Tissu-Trans Syringe Fill

Version/Model Number

Linear Syringe Fill 60X3

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102117

Product Code Details

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Device Record Status

Public Device Record Key

8556bc59-0636-4c0c-8480-4f01ef51eb85

Public Version Date

January 08, 2021

Public Version Number

7

DI Record Publish Date

August 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHIPPERT MEDICAL TECHNOLOGIES, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 567
2 A medical device with a moderate to high risk that requires special controls. 13