OTC S833

GUDID 00810000525744

OTC Remover in 4 Liter Bottle

PARKELL, INC.

Denture reliner, soft, professional
Primary Device ID00810000525744
NIH Device Record Key7f9b516b-402f-4fa5-9858-fce8655df4e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTC
Version Model NumberS833
Catalog NumberS833
Company DUNS009900424
Company NamePARKELL, INC.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator with cap or used mixing tip tightly attached. Avoid freezing. Allow chilled material to come to room temperature. Avoid excessive heat, light or fresh eugenol-containing material

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000525744 [Primary]

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-08
Device Publish Date2024-06-28

On-Brand Devices [OTC]

00810000525591OTC Primer in 4-Litre Bottles
00810000525744OTC Remover in 4 Liter Bottle

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