Frigitronics
- Primary DI
- 00888937004151
- Brand
- Frigitronics
- Company
- Coopersurgical, Inc.
- Model
- 125
- Device description
- Retinal, Curved Probe. Tip: 2.5mm diameter. Shaft: 38mm length x 2.5mm diameter.
- Published
- 2016-07-20
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| HQA | Unit, Cryotherapy, Ophthalmic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HQA | Unit, Cryotherapy, Ophthalmic | Ophthalmic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00888937004151 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00888937004151 | 00888937004151 | 888937004151 | 0888937004151 |
GMDN Terms
| Term | Definition |
|---|
| Ophthalmic cryosurgical system applicator, retinal | A hand-held device that is a component of an electronic ophthalmic cryosurgical system designed for the application of cold, produced by a cryogen from a cylinder connected via the system control unit, to retinal tissue for various therapeutic applications (e.g., to treat retinal tears and detachments) during ophthalmic surgery. It is typically formed as a handpiece with an insulated grip and attached tubing with connector for attachment to the control unit, and is available with a variety of tip configurations (e.g., curved, midreach, right angle, extended reach). This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization;Ethylene Oxide |
Regulatory Flags
- DUNS number
- 801895244
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10817489026615 | 23ga MultiFlex™ Extendable Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | HQA | 2017-12-17 |
| 00888937019896 | Trichiasis | Coopersurgical, Inc. | HQA | 2017-09-27 |
| 00888937009422 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-08-02 |
| 00888937004052 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004069 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004076 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004083 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004090 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004106 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004113 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004120 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004137 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004144 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004168 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004175 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004182 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004199 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004205 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004212 | Frigitronincs | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004229 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004236 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004243 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004250 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004267 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004274 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004281 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004298 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004304 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004311 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |
| 00888937004328 | Frigitronics | Coopersurgical, Inc. | HQA | 2016-07-20 |