The Original Clearsplint Disc PCSD16

GUDID D810PCSD1698111

Mouthguard, single-use

Primary Device ID	D810PCSD1698111
NIH Device Record Key	7980d787-377f-44ee-b9b7-6b1d358e5d7a
Commercial Distribution Status	In Commercial Distribution
Brand Name	The Original Clearsplint Disc
Version Model Number	PCSD16
Catalog Number	PCSD16
Company DUNS	056624901
Company Name	ASTRON DENTAL CORPORATION
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	true
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

Device Issuing Agency	Device ID
HIBCC	D810PCSD1698111 [Primary]

MQC	Mouthguard, Prescription

Steralize Prior To Use	false
Device Is Sterile	false

D810PCSD985111	Package of 1 disc 98mmX20mm with shoulder
D810PCSD2098NS111	Package of 1 disc 98mmX20mm with no shoulder
D810PCSD2095Z111	Package of 1 disc 95mmX20mm Zirkonzahn/Clover Leaf Edge
D810PCSD1698111	Package of 1 disc 98mmX16mm with shoulder