Duns Number:690584057
Device Description: SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in SUPARTZ (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 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 rooster 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 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
7156-5555
Brand Name
SUPARTZ® sodium hyaluronate
Version/Model Number
89130-5555-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2018
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
P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044,P980044
Product Code
MOZ
Product Code Name
Acid, Hyaluronic, Intraarticular
Public Device Record Key
371322d8-acc6-45c8-b0bb-d894576b9a7f
Public Version Date
July 31, 2018
Public Version Number
4
DI Record Publish Date
January 31, 2017
Package DI Number
M717715655554
Quantity per Package
1
Contains DI Package
M717715655553
Package Discontinue Date
July 31, 2018
Package Status
Not in Commercial Distribution
Package Type
Shipping Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 3 |