VISCO-3 sodium hyaluronate
Basic Information
- Brand Name
- VISCO-3 sodium hyaluronate
- Primary DI
- 04987541301314
- Version / Model
- 00-1111-001-03
- Catalog Number
- 00-1111-001-03
- Company Name
- SEIKAGAKU CORPORATION
- Labeler DUNS
- 690584057
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-22
- Public Version
- 11
- Public Version Date
- 2022-04-12
- Public Version Status
- Update
- Public Device Record Key
- 9b69a0b2-e472-49c8-a297-9c0057880566
Device Description
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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MOZ | Acid, Hyaluronic, Intraarticular | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44757 | Synovial fluid supplementation medium | A sterile viscous/elastic solution or gel (e.g., comprised of hyaluronic acids and their polymeric derivatives) intended to be injected into joints (particularly large, load-bearing joints such as the hip or knee) to help cushion the joint, especially in cases of endogenous synovial fluid reduced viscosity from degenerative disease. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987541301314 | GS1 | ||||
| Package | 14987541301311 | GS1 | Outer Box | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- 5743724999
- [email protected]
- Phone
- 8003482759
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P980044 | 027 |
| P980044 | 028 |
| P980044 | 032 |
| P980044 | 033 |
| P980044 | 034 |
| P980044 | 035 |
| P980044 | 036 |
| P980044 | 037 |
| P980044 | 038 |
| P980044 | 040 |
| P980044 | 041 |
| P980044 | 042 |
| P980044 | 043 |
| P980044 | 045 |
| P980044 | 046 |
| P980044 | 047 |
| P980044 | 048 |
| P980044 | 049 |
| P980044 | 050 |
| P980044 | 051 |
| P980044 | 053 |
| P980044 | 054 |
| P980044 | 055 |
| P980044 | 056 |
| P980044 | 057 |
| P980044 | 058 |
| P980044 | 059 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius