HurriSeal Dentin Desensitizer 5mL

GUDID 01723797697145

5mL bottle - Dentin desensitizing liquid formula.

BEUTLICH PHARMACEUTICALS, LLC

Dental coating, tooth-desensitizing
Primary Device ID01723797697145
NIH Device Record Key76441824-1fca-4596-81ba-03cfe3287e98
Commercial Distribution StatusIn Commercial Distribution
Brand NameHurriSeal Dentin Desensitizer 5mL
Version Model Number5mL 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
Phone1-800-238-8542
Emailregulatory@beutlich.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS101723797697145 [Primary]
GS102723797697144 [Package]
Package: case of 72 [72 Units]
Discontinued: 2022-12-31
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 Number5
Public Version Date2020-01-08
Device Publish Date2016-10-01

On-Brand Devices [HurriSeal Dentin Desensitizer 5mL]

017237976971455mL bottle - Dentin desensitizing liquid formula.
10723797697143Dentin desensitizing liquid formula. 1 x 5mL bottle in box

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