HurriSeal Dentin Desensitizer Snap-N-Go Swab

GUDID 02723797697113

Single swab applicator - Dentin desensitizing liquid formula

BEUTLICH PHARMACEUTICALS, LLC

Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, home-use Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional
Primary Device ID02723797697113
NIH Device Record Keye139c151-5199-43f9-914e-13b28cb3f8ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameHurriSeal Dentin Desensitizer Snap-N-Go Swab
Version Model NumberSnap-N-Go Swab
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 Usetrue
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
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
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
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
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
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.
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.
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.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100723797697115 [Primary]
GS101723797697114 [Package]
Contains: 00723797697115
Package: 2 count box [2 Units]
Discontinued: 2021-04-30
In Commercial Distribution
GS101723797697473 [Package]
Contains: 00723797697115
Package: 36 count box [36 Units]
Discontinued: 2021-04-30
In Commercial Distribution
GS101723797697589 [Package]
Contains: 00723797697115
Package: 12 count clamshell [12 Units]
Discontinued: 2021-04-30
In Commercial Distribution
GS102723797697113 [Package]
Contains: 00723797697115
Package: 3000 count bulk case [3000 Units]
Discontinued: 2021-04-30
In Commercial Distribution
GS102723797697588 [Package]
Contains: 01723797697589
Package: case of 156 12 count [156 Units]
Discontinued: 2021-04-30
In Commercial Distribution
GS110723797697471 [Package]
Contains: 00723797697115
Package: 36 count box [36 Units]
In Commercial Distribution
GS110723797697587 [Package]
Contains: 00723797697115
Package: 12 count clamshell [12 Units]
In Commercial Distribution
GS120723797697119 [Package]
Contains: 00723797697115
Package: 2 count box [2 Units]
In Commercial Distribution
GS120723797697584 [Package]
Contains: 10723797697587
Package: Case of 156 [156 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 Number5
Public Version Date2020-01-08
Device Publish Date2016-10-01

Devices Manufactured by BEUTLICH PHARMACEUTICALS, LLC

10723797697143 - HurriSeal Dentin Desensitizer 5mL2020-11-05 Dentin desensitizing liquid formula. 1 x 5mL bottle in box
10723797697822 - HurriSeal Dentin Desensitizer 12mL2020-11-05 Dentin desensitizing liquid formula. 1 x 12mL bottle in a box.
01723797697145 - HurriSeal Dentin Desensitizer 5mL2020-01-08 5mL bottle - Dentin desensitizing liquid formula.
01723797697824 - HurriSeal Dentin Desensitizer 12mL2020-01-08 12mL bottle - dentin desensitizing liquid formula.
02723797104727 - HurriView2020-01-08 HurriView Plaque Disclosing Liquid - swab, each
02723797110575 - HurriView II2020-01-08 Two-Tone Dental Plaque Disclosing Liquid; swab, each
02723797697113 - HurriSeal Dentin Desensitizer Snap-N-Go Swab2020-01-08Single swab applicator - Dentin desensitizing liquid formula
02723797697113 - HurriSeal Dentin Desensitizer Snap-N-Go Swab2020-01-08 Single swab applicator - Dentin desensitizing liquid formula

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.