Bluegrass Roller

GUDID 00192029049648

Orthodontic retainer

Primary Device ID	00192029049648
NIH Device Record Key	05f59b46-6f21-4d52-b279-3be4218a692c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Bluegrass Roller
Version Model Number	611-025
Company DUNS	005432299
Company Name	TP ORTHODONTICS INC
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	false
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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00192029049648 [Primary]

DYJ	RETAINER, SCREW EXPANSION, ORTHODONTIC

Steralize Prior To Use	false
Device Is Sterile	false

00192029050491 - Cuspid Laminated Mesh	2024-01-05 MISC. BRACKETS
00192029043264 - Foam Pellets	2023-10-13 ADHESIVE, BRACKET-Tooth Conditioner, Resin
00192029043271 - Bonding Accessories	2023-10-13 ADHESIVE, BRACKET-Tooth Conditioner, Resin
00192029043288 - Bonding Accessories	2023-10-13 ADHESIVE, BRACKET-Tooth Conditioner, Resin
00192029017494 - Tip-Edge SL PLUS Stainless Steel Brackets	2022-10-25 SL PLUS NON EXT 22 KIT
00192029017500 - Tip-Edge SL PLUS Stainless Steel Brackets	2022-10-25 SL PLUS NON EXT 22 KIT OR
00192029017517 - Tip-Edge SL PLUS Stainless Steel Brackets	2022-10-25 SL TE PLUS UL CEN 22
00192029017524 - Tip-Edge SL PLUS Stainless Steel Brackets	2022-10-25 SL TE PLUS UR CEN 22