FDA UDI
In Commercial Distribution
🇺🇸 United States
Cryo Probe: Extended Retinal, 2.5mm
DI: 08717872021416
·
Model: 1540.D
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cryo Probe: Extended Retinal, 2.5mm
- Primary DI
- 08717872021416
- Version / Model
- 1540.D
- Catalog Number
- 1540.D
- Company Name
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Labeler DUNS
- 407522184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-12
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a3c9012a-412f-4ecc-9abd-03c51b73a752
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 |
|---|---|---|---|---|
| HRN | Unit, Cryophthalmic, Ac-Powered | Ophthalmic | 886.4170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46052 | Ophthalmic cryosurgical system, electronic | An assembly of mains electricity (AC-powered) devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal during an ophthalmic surgical procedure. The system typically includes an electronic control unit which controls the flow of cryogen contained in a connected cylinder, dedicated cryogen-cooled hand-held applicators (probes) to apply the cold to the tissue, a foot-switch, and interconnections. It is commonly used for cryopexy for retinal detachment, cataract extraction, and to treat glaucoma, trichiasis, and retinopathy of prematurity (ROP). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872021416 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160591 | 000 |