Supartz - PROPHARMA-UK LTD

Duns Number:221768159

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More Product Details

Catalog Number

-

Brand Name

Supartz

Version/Model Number

NA

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

-

Product Code Details

Product Code

MOZ

Product Code Name

Acid, Hyaluronic, Intraarticular

Device Record Status

Public Device Record Key

f4f65e31-859f-4d7b-9a07-005e09adc396

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROPHARMA-UK LTD" Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 4