Duns Number:690584057
Device Description: VISCO-3 (P980044/S027) is indicated for treatment of pain in osteoarthritis (OA) of the kn VISCO-3 (P980044/S027) 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.VISCO-3 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. VISCO-3 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
00-1111-001-03
Brand Name
VISCO-3 sodium hyaluronate
Version/Model Number
00-1111-001-03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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,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
9b69a0b2-e472-49c8-a297-9c0057880566
Public Version Date
April 12, 2022
Public Version Number
11
DI Record Publish Date
March 22, 2017
Package DI Number
14987541301311
Quantity per Package
3
Contains DI Package
04987541301314
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 3 |