Histofreezer
GUDID 10608337365150
Histofreezer, Kit, U.S., 36F1C
Orasure Technologies, Inc.
General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 10608337365150 |
| NIH Device Record Key | 9b0e3f41-2095-4a85-8040-0054f1a88c9b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Histofreezer |
| Version Model Number | 1001-0294 |
| Company DUNS | 114152184 |
| Company Name | Orasure Technologies, 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 | 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 | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com | |
| Phone | 610-882-1820 |
| customercare@orasure.com |
Operating and Storage Conditions
| 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 *Protect from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight |
| Storage 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight |
| Storage 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight |
| Storage 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight |
| Storage 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight |
| Storage 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight |
| Storage 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight |
| Storage 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00608337365108 [Primary] |
| GS1 | 10608337365150 [Package] Contains: 00608337365108 Package: [5 Units] In Commercial Distribution |
FDA Product Code
| GEH | Unit, Cryosurgical, Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [Histofreezer]
| 10608337402152 | Histofreezer Kit, U.S., 40T1C |
| 10608337365150 | Histofreezer, Kit, U.S., 36F1C |
| 10608337360155 | Histofreezer Kit, U.S., 36M1C |
| 00608337001297 | Histofreezer, US Sample, 5M1C |
| 10608337000556 | Histofreezer Kit, U.S., 60MC2 +10 |
Trademark Results [Histofreezer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HISTOFREEZER 73741009 1525479 Live/Registered |
KONINKLIJKE UTERMOHLEN N.V. 1988-07-20 |
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