FDA UDI
In Commercial Distribution
🇺🇸 United States
VersaVit
DI: 10841305106045
·
Model: VERSAVIT
·
SYNERGETICS USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VersaVit
- Primary DI
- 10841305106045
- Version / Model
- VERSAVIT
- Catalog Number
- VERSAVIT
- Company Name
- SYNERGETICS USA, INC.
- Labeler DUNS
- 021056726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 4
- Public Version Date
- 2018-10-29
- Public Version Status
- Update
- Public Device Record Key
- 20e87d2f-0a88-44df-a477-c43c3afb0421
Device Description
VersaVIT™ Vitrectomy System
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQE | INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED | Ophthalmic | 886.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45074 | Vitrectomy system | An assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric, pneumatic) through a dedicated hand-held instrument, which converts the energy into an oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This system will typically consist of a generator to provide the energy, an infusion and suction system to supply replacement fluid and remove debris, a cutting handpiece and cables, and a foot control. This assembly is typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841305106045 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit