FDA UDI
In Commercial Distribution
🇺🇸 United States
GenVisc 850 Sodium Hyaluronate
DI: 00193493000753
·
Model: 50653-0006-01
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- GenVisc 850 Sodium Hyaluronate
- Primary DI
- 00193493000753
- Version / Model
- 50653-0006-01
- Catalog Number
- 50653-0006-01
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-06
- Public Version
- 1
- Public Version Date
- 2024-03-14
- Public Version Status
- New
- Public Device Record Key
- d7023f52-71c7-4851-8745-fab6bc7ff4ae
Device Description
GenVisc 850
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 |
|---|---|---|---|---|---|---|
| Package | 10193493000750 | GS1 | CS | 50 | In Commercial Distribution | |
| Primary | 00193493000753 | GS1 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140005 | 005 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 25 MG / 2.5 mL |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 33.8 – 86 Degrees Fahrenheit