| Primary Device ID | 00850077006029 |
| NIH Device Record Key | 321c56ab-ced6-4cc0-86cf-6201b9454da7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FREEZPOINT™ |
| Version Model Number | CRY8 |
| Catalog Number | CRY8 |
| Company DUNS | 079940465 |
| Company Name | BOVIE MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Exposed to temperatures exceeding 50 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Exposed to temperatures exceeding 50 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850077006029 [Primary] |
| GEH | Unit, Cryosurgical, Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-26 |
| 00850077006029 | FREEZE POINT™ MULTI-USE DISPOSABLE CRYOSURGICAL DEVICE - 8G |
| 00850077006012 | FREEZE POINT™ MULTI-USE DISPOSABLE CRYOSURGICAL DEVICE - 16G |