Histofreezer

GUDID 10608337402152

Histofreezer Kit, U.S., 40T1C

Orasure Technologies, Inc.

General cryosurgical system, cryogen gas, mechanical
Primary Device ID10608337402152
NIH Device Record Key16681592-6251-4a44-b03c-48aef7c9da9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHistofreezer
Version Model Number1001-0293
Company DUNS114152184
Company NameOrasure Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100608337402100 [Primary]
GS110608337402152 [Package]
Contains: 00608337402100
Package: [5 Units]
In Commercial Distribution

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-15

On-Brand Devices [Histofreezer]

10608337402152Histofreezer Kit, U.S., 40T1C
10608337365150Histofreezer, Kit, U.S., 36F1C
10608337360155Histofreezer Kit, U.S., 36M1C
00608337001297Histofreezer, US Sample, 5M1C
10608337000556Histofreezer Kit, U.S., 60MC2 +10

Trademark Results [Histofreezer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HISTOFREEZER
HISTOFREEZER
73741009 1525479 Live/Registered
KONINKLIJKE UTERMOHLEN N.V.
1988-07-20

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