Verruca-Freeze VFK65
GUDID 00865715000345
Verruca-Freeze 65 Freeze Kit (175mL)
CryoSurgery, Inc.
General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 00865715000345 |
| NIH Device Record Key | 30f326c3-66c2-4fe7-930a-b122e048db1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Verruca-Freeze |
| Version Model Number | VFK65 |
| Catalog Number | VFK65 |
| Company DUNS | 793483256 |
| Company Name | CryoSurgery, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com | |
| Phone | +1 (615) 354-0414 |
| info@cryosurgeryinc.com |
Device Dimensions
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
| Total Volume | 175 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store near direct heat source |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00865715000345 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K982506
FDA Product Code
| GEH | Unit, Cryosurgical, Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-27 |
| Device Publish Date | 2023-04-19 |
On-Brand Devices [Verruca-Freeze]
| 00865715000383 | Verruca-Freeze 50 Freeze Kit (150mL) |
| 00865715000352 | Verruca-Freeze 45 Freeze Introductory Kit (135mL) |
| 00865715000345 | Verruca-Freeze 65 Freeze Kit (175mL) |
| 00865715000338 | Verruca-Freeze 40 Freeze Trial Kit (120mL) |
| 00865715000321 | Verruca-Freeze 100 Freeze Replacement Canister (236mL) |
| 00865715000314 | Verruca-Freeze 50 Freeze Replacement Canister (150mL) |
| 00865715000307 | Verruca-Freeze 65 Freeze Replacement Canister (175mL) |
| 00865715000390 | Verruca-Freeze 175ml Replacement Canister Twin Pack (350ml) |
| 00865715000376 | Verruca-Freeze 236ml Replacement Canister Triple Pack (708ml) |
| 00865715000369 | Verruca-Freeze 236ml Replacement Canister Twin Pack (472ml) |
Trademark Results [Verruca-Freeze]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERRUCA-FREEZE 76676048 3364170 Live/Registered |
CryoSurgery, Inc. 2007-04-26 |
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