FDA UDI
In Commercial Distribution
🇺🇸 United States
Abraham Iridectomy Laser Lens
DI: 00630238007016
·
Model: OAIA
·
OCULAR INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Abraham Iridectomy Laser Lens
- Primary DI
- 00630238007016
- Version / Model
- OAIA
- Company Name
- OCULAR INSTRUMENTS, INC.
- Labeler DUNS
- 046212387
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-06
- Public Version
- 4
- Public Version Date
- 2018-09-24
- Public Version Status
- Update
- Public Device Record Key
- d7f60a08-af0b-4a37-b0ed-ca71441a0903
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | Ophthalmic | 886.1385 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40238 | Laser lens, ophthalmic, surgical | A device designed to modify the convergence of the rays of light of an ophthalmic laser beam used to coagulate or cut tissues of the eye, the orbit, or the surrounding skin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630238007016 | GS1 | ||||
| Direct Marking | 00630238020367 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K863027 | 000 |