Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL
Basic Information
- Brand Name
- Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL
- Primary DI
- M71389122072420A1
- Version / Model
- 89122-0724-20
- Catalog Number
- 89122-0724-20
- Company Name
- FIDIA FARMACEUTICI SPA
- Labeler DUNS
- 428453013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-31
- Public Version
- 4
- Public Version Date
- 2021-03-25
- Public Version Status
- Update
- Public Device Record Key
- ddad4099-2f1d-470f-b65a-af8738f6baeb
Device Description
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
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 | M71389122072420A1 | HIBCC |
Customer Contacts
- Phone
- 9735776202
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P950027 | 006 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in original packaging (protected from light)
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store Below 77°F
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Freeze