Duns Number:690584057
Device Description: SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
Catalog Number
7156-4444
Brand Name
SUPARTZ FX sodium hyaluronate
Version/Model Number
89130-4444-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
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Product Code
MOZ
Product Code Name
Acid, Hyaluronic, Intraarticular
Public Device Record Key
700569e3-2bfc-4225-ae20-47d484261471
Public Version Date
April 11, 2022
Public Version Number
10
DI Record Publish Date
January 31, 2017
Package DI Number
M717715644442
Quantity per Package
5
Contains DI Package
M717715644440
Package Discontinue Date
-
Package Status
-
Package Type
Outer Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 3 |