Biotrol PGC113CI

GUDID 10302730000129

First Choice Prophy Gems Prophy Paste, Fluoride, Coarse Grit, 2 g, Cinnamon

YOUNG DENTAL MANUFACTURING I, LLC

Dentifrice

• Primary Device ID: 10302730000129
• NIH Device Record Key: 342b8663-8a96-4e03-ba46-e5facb18c8a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotrol
• Version Model Number: PGC113CI
• Catalog Number: PGC113CI
• Company DUNS: 006309355
• Company Name: YOUNG DENTAL MANUFACTURING I, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature. Do FALSEt allow to freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00302730000122 [Primary]
GS1	10302730000129 [Package]; Contains: 00302730000122; Package: Box [100 Units]; In Commercial Distribution
GS1	20302730000126 [Package]; Contains: 00302730000122; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• EJR: AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-24
• Device Publish Date: 2022-10-16

On-Brand Devices [Biotrol]

• 10302735146501: Biotrol DPA Perfect Choice, Latex Free, Soft, Short, Gray Web Cup, Snap On Type
• 20302735146102: Biotrol DPA Perfect Choice, Latex Free, Soft, Short, Gray Web Cup, Snap On Type
• 10302732959999: Birex Quat RTU 1 Gal, M60060, 4 per case - Disinfectant
• 20302732955073: Wipes, Birex Quat, 160 ct - Disinfectant
• 20302730002335: Biotrol Biocide G30 Glutaraldehyde, Instrument Cleaner, 1 Gallon x 4ct
• 10302730001577: Biotrol Purit Cide-it III, Ultrasonic Instrument Cleaner, 16oz
• 10302730000433: Birex SE III, Operatory Pack, 12pk (12 x 1 fl oz) - Disinfectant
• 10302730000426: Birex SE III, Introductory Pack, 6 pk - 1 fl oz pkt (9346SE) - Disinfectant
• 10302730000419: Birex SE III, Clinic Pack, 36pk (36 x 1 fl oz) - Disinfectant
• 20302730000232: First Choice Prophy Gems Prophy Paste, Fluoride, Extra Coarse Grit, 2 g, Cool Mint
• 20302730000218: First Choice Prophy Gems Prophy Paste, Fluoride, Medium Grit, 2 g, Assorted
• 10302730000204: First Choice Prophy Gems Prophy Paste, Fluoride, Medium Grit, 2 g, Wild Berry
• 10302730000198: First Choice Prophy Gems Prophy Paste, Fluoride, Medium Grit, 2 g, Cinnamon
• 10302730000181: First Choice Prophy Gems Prophy Paste, Fluoride, Medium Grit, 2 g, Cool Mint
• 10302730000174: First Choice Prophy Gems Prophy Paste, Fluoride, Fine Grit, 2 g, Bubblegum
• 10302730000167: First Choice Prophy Gems Prophy Paste, Fluoride, Fine Grit, 2 g, Cool Mint
• 20302730000140: First Choice Prophy Gems Prophy Paste, Fluoride, Coarse Grit, 2 g, Assorted
• 10302730000136: First Choice Prophy Gems Prophy Paste, Fluoride, Coarse Grit, 2 g, Wild Berry
• 10302730000129: First Choice Prophy Gems Prophy Paste, Fluoride, Coarse Grit, 2 g, Cinnamon
• 20302730000119: First Choice Prophy Gems Prophy Paste, Fluoride, Coarse Grit, 2 g, Cool Mint
• 10302730000082: Biotrol Surgical Evacuation Tips, Green, .25? (6.4mm), Autoclavable Aspiration Instrument
• 10302730000075: Biotrol Surgical Evacuation Tips, White, .16? (4mm), Autoclavable Aspiration Instrument
• 10302730000068: OPTI-CIDE 2 x 2.5 GAL Solution - RTU Disinfectant (BIOTROL)
• 10302730000051: OPTI-CIDE 1 GAL Solution - RTU Disinfectant (BIOTROL)
• 10302730000044: OPTI-CIDE 24OZ Solution - Disinfectant (BIOTROL)
• 10302730000037: OPTI-CIDE WIPES, 100 ct - Disinfectant (BIOTROL)
• 00302730003161: PURIT ENZ-IT 16 oz.
• 10302730000402: RESTORE DAILY 16OZ BLT
• 10302730002086: PURIT CLEAN-IT 16 oz.
• 10302730000365: BIOZYME-LT 32 OZ BOTTLE