FDA UDI
In Commercial Distribution
🇺🇸 United States
Frigitronics
DI: 00888937004267
·
Model: 237
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Frigitronics
- Primary DI
- 00888937004267
- Version / Model
- 237
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-20
- Public Version
- 4
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 81d23a18-80d1-47ee-959c-3922f04f1f33
Device Description
Cryoanalgesia, 19 Gauge Round Tip Probe. Tip: 1.0mm length x 1.0mm diameter. Shaft: 100mm length x 1.0mm diameter.
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
- Yes
- 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
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQA | Unit, Cryotherapy, Ophthalmic | Ophthalmic | 886.4170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17140 | Cryogenic analgesia unit | A device designed to provide analgesia (the alleviation of pain) by applying extremely low temperatures (freezing) to body tissues. The device consists of a cryostat and cooling probe, and sometimes a peripheral nerve-block stimulator (nerve stimulator). This device will incorporate some method of protecting the tissue it is being applied to against permanent damage (e.g., freeze-thaw cycles). Cryogenic analgesia results in reversible, though prolonged (weeks/months), peripheral nerve-block and is used for postoperative and chronic intractable pain relief. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937004267 | GS1 |