VISCO-3 sodium hyaluronate
- Primary DI
- 04987541301314
- Brand
- VISCO-3 sodium hyaluronate
- Company
- SEIKAGAKU CORPORATION
- Model
- 00-1111-001-03
- Catalog number
- 00-1111-001-03
- 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).
- Published
- 2017-03-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| MOZ | Acid, Hyaluronic, Intraarticular |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MOZ | Acid, Hyaluronic, Intraarticular | Unknown | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| 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 |
| P980044 | 062 |
| P980044 | 065 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| P980044 | 027 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 028 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 032 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 033 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 034 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 035 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 036 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 037 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 038 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 040 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 041 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 042 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 043 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 045 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 046 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 047 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 048 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 049 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 050 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 051 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 053 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 054 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 055 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 056 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 057 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 058 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 059 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 062 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
| P980044 | 065 | SUPARTZ FX | Seikagaku Corp. | 2001-01-24 | MOZ |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 14987541301311 | Package | GS1 | 3 | In Commercial Distribution |
| 04987541301314 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 14987541301311 | 14987541301311 | |
| 04987541301314 | 04987541301314 | 4987541301314 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 Degrees Celsius | 25 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 5743724999 | xxx@xxx.xxx |
| 8003482759 | xxx@xxx.xxx |
Regulatory Flags#
- DUNS number
- 690584057
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| M717715644440 | SUPARTZ FX sodium hyaluronate | 89130-4444-1 | 7156-4444 | 2017-01-31 |
| 04987541300911 | Gel-One® Cross-linked Hyaluronate | 00-1111-001-00 | 00-1111-001-00 | 2020-01-15 |
| 00087541300912 | Gel-One® Cross-linked Hyaluronate | 00-1111-001-00 | 00-1111-001-00 | 2014-09-17 |
| M717715655550 | SUPARTZ® sodium hyaluronate | 89130-5555-01 | 7156-5555 | 2017-01-31 |
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