SUPARTZ FX sodium hyaluronate
Basic Information
- Brand Name
- SUPARTZ FX sodium hyaluronate
- Primary DI
- M717715644440
- Version / Model
- 89130-4444-1
- Catalog Number
- 7156-4444
- Company Name
- SEIKAGAKU CORPORATION
- Labeler DUNS
- 690584057
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-31
- Public Version
- 11
- Public Version Date
- 2023-11-01
- Public Version Status
- Update
- Public Device Record Key
- 700569e3-2bfc-4225-ae20-47d484261471
- Distribution End Date
- 2026-10-31
Device Description
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).
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 | M717715644440 | HIBCC | ||||
| Package | M717715644442 | HIBCC | Outer Box | 5 | Not in Commercial Distribution | 2026-10-31 |
| Package | M717715644443 | HIBCC | Packing Case | 36 | Not in Commercial Distribution | 2026-10-31 |
| Package | M717715644444 | HIBCC | Shipping Carton | 1 | In Commercial Distribution | 2026-10-31 |
Customer Contacts
- Phone
- 8003964325
- [email protected]
- Phone
- 9194746700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P980044 | 019 |
| P980044 | 020 |
| P980044 | 021 |
| P980044 | 022 |
| P980044 | 023 |
| P980044 | 024 |
| P980044 | 025 |
| P980044 | 026 |
| P980044 | 027 |
| P980044 | 028 |
| P980044 | 029 |
| P980044 | 030 |
| P980044 | 031 |
| 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