FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniView 145
DI: 00850054345189
·
Model: P-IOV-017
·
Ion Vision, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OmniView 145
- Primary DI
- 00850054345189
- Version / Model
- P-IOV-017
- Company Name
- Ion Vision, Inc
- Labeler DUNS
- 010759642
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 1
- Public Version Date
- 2023-08-31
- Public Version Status
- New
- Public Device Record Key
- 234ddd58-e3b2-4d89-a6a3-c8aa9f5f61e7
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HJL | Lens, Condensing, Diagnostic | Ophthalmic | 886.1380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32287 | Surgical camera lens | An optical element of a surgical camera designed to change the degree of convergence or divergence of transmitted light to enable modification of viewed images (e.g., magnification, wide angle). It is made of glass and is available in a variety of dimensions. This is a non-sterilizable, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850054345189 | GS1 |