Histofreezer 60MC2 + 10
GUDID 00850077006128
Histofreezer, Kit, U.S., 60MC2 + 10 The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
CRYOCONCEPTS, LP
General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 00850077006128 |
| NIH Device Record Key | 49b9ab7e-a312-445e-ac7c-36c4f7ca0ed0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Histofreezer |
| Version Model Number | 1001-0375 |
| Catalog Number | 60MC2 + 10 |
| Company DUNS | 038024868 |
| Company Name | CRYOCONCEPTS, LP |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com | |
| Phone | 1-855-355-2796 |
| support@cryoconcepts.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850077006128 [Primary] |
| GS1 | 10850077006125 [Package] Package: Kit [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K990877
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 | 2020-09-30 |
| Device Publish Date | 2020-09-22 |
On-Brand Devices [Histofreezer]
| 10850077006095 | Histofreezer, Kit U.S, 36F1C The Histofreezer Portable Cryosurgical System is used for the remov |
| 00850077006128 | Histofreezer, Kit, U.S., 60MC2 + 10 The Histofreezer Portable Cryosurgical System is used for th |
| 10850077006118 | Histofreezer, Kit, U.S., 5M1C The Histofreezer Portable Cryosurgical System is used for the remo |
| 10850077006101 | Histofreezer, Kit, U.S., 36M1C The Histofreezer Portable Cryosurgical System is used for the rem |
| 10850077006088 | Histofreezer, Kit, U.S., 40T1C The Histofreezer Portable Cryosurgical System is used for the rem |
Trademark Results [Histofreezer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HISTOFREEZER 73741009 1525479 Live/Registered |
KONINKLIJKE UTERMOHLEN N.V. 1988-07-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.