HurriSeal Dentin Desensitizer 12mL

GUDID 10723797697822

Dentin desensitizing liquid formula. 1 x 12mL bottle in a box.

BEUTLICH PHARMACEUTICALS, LLC

Dental coating, tooth-desensitizing, professional
Primary Device ID10723797697822
NIH Device Record Keydaecb5d6-3ece-4cba-8542-4dfd52888f6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHurriSeal Dentin Desensitizer 12mL
Version Model Number12mL bottle
Company DUNS005209325
Company NameBEUTLICH PHARMACEUTICALS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS101723797697824 [Previous]
GS110723797697822 [Primary]
GS120723797697829 [Package]
Package: 72 in a case [72 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-11-05
Device Publish Date2020-01-07

On-Brand Devices [HurriSeal Dentin Desensitizer 12mL]

0172379769782412mL bottle - dentin desensitizing liquid formula.
10723797697822Dentin desensitizing liquid formula. 1 x 12mL bottle in a box.

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