primosplint system

GUDID D831PSKIT1

Dental occlusal splint, custom-made

Primary Device ID	D831PSKIT1
NIH Device Record Key	284096d6-cbe9-4451-a5ac-bf8139bdc404
Commercial Distribution Status	In Commercial Distribution
Brand Name	primosplint system
Version Model Number	PSKIT1
Company DUNS	153454736
Company Name	PRIMOTEC LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D831PSKIT1 [Primary]

MQC	Mouthguard, Prescription

Steralize Prior To Use	false
Device Is Sterile	false