FDA UDI
In Commercial Distribution
🇺🇸 United States
SYNVISC ONE
DI: 08437027710049
·
Model: 58468-0090-3
·
SAIMA GLOBAL FARMA S.L.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SYNVISC ONE
- Primary DI
- 08437027710049
- Version / Model
- 58468-0090-3
- Company Name
- SAIMA GLOBAL FARMA S.L.
- Labeler DUNS
- 468910220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-13
- Public Version
- 1
- Public Version Date
- 2024-11-21
- Public Version Status
- New
- Public Device Record Key
- 27d615f2-48d3-43bb-8f92-c216a8e766c6
Device Description
SYNVISC ONE (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. SYNVISC ONE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
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 | 08437027710049 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P940015 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius