FDA UDI
In Commercial Distribution
🇺🇸 United States
Gel-One® Cross-linked Hyaluronate
DI: 04987541300911
·
Model: 00-1111-001-00
·
SEIKAGAKU CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gel-One® Cross-linked Hyaluronate
- Primary DI
- 04987541300911
- Version / Model
- 00-1111-001-00
- Catalog Number
- 00-1111-001-00
- Company Name
- SEIKAGAKU CORPORATION
- Labeler DUNS
- 690584057
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-15
- Public Version
- 14
- Public Version Date
- 2023-12-14
- Public Version Status
- Update
- Public Device Record Key
- fe177b2d-8b74-4efd-b3a5-24e18a158a1b
Device Description
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
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 | 04987541300911 | GS1 |
Customer Contacts
- Phone
- 5743724999
- [email protected]
- Phone
- 8003482759
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080020 | 012 |
| P080020 | 013 |
| P080020 | 014 |
| P080020 | 015 |
| P080020 | 016 |
| P080020 | 017 |
| P080020 | 018 |
| P080020 | 019 |
| P080020 | 020 |
| P080020 | 021 |
| P080020 | 022 |
| P080020 | 023 |
| P080020 | 024 |
| P080020 | 025 |
| P080020 | 027 |
| P080020 | 028 |
| P080020 | 029 |
| P080020 | 030 |
| P080020 | 031 |
| P080020 | 032 |
| P080020 | 033 |
| P080020 | 035 |
| P080020 | 036 |
| P080020 | 037 |
| P080020 | 038 |
| P080020 | 039 |
| P080020 | 040 |
| P080020 | 042 |
| P080020 | 043 |
| P080020 | 044 |
| P080020 | 045 |
| P080020 | 046 |
| P080020 | 047 |
| P080020 | 048 |
| P080020 | 049 |
| P080020 | 051 |
| P080020 | 052 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius