FDA UDI
In Commercial Distribution
🇺🇸 United States
Two Mirror Gonio Diagnostic Lens NMR-Kapetensky
DI: 00630238007917
·
Model: O2M-2
·
OCULAR INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Two Mirror Gonio Diagnostic Lens NMR-Kapetensky
- Primary DI
- 00630238007917
- Version / Model
- O2M-2
- Company Name
- OCULAR INSTRUMENTS, INC.
- Labeler DUNS
- 046212387
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-11
- Public Version
- 2
- Public Version Date
- 2021-03-17
- Public Version Status
- Update
- Public Device Record Key
- 196c3f10-fb54-4299-abaa-5b56200a2e07
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HKS | Prism, Gonioscopic | Ophthalmic | 886.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11894 | Gonioscope | A device intended to be used to examine the angle of the anterior chamber of the eye and for demonstrating ocular motility and rotation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630238007917 | GS1 | ||||
| Direct Marking | 00630238031448 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K895846 | 000 |