Matrix Band Primary Tooth

GUDID D77940920118

COSMEDENT, INC.

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Primary Device ID	D77940920118
NIH Device Record Key	61331fa3-cba2-4242-bb96-90fcb616f19e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Matrix Band Primary Tooth
Version Model Number	409201
Company DUNS	113911689
Company Name	COSMEDENT, 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	true
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D77940920118 [Primary]

FDA Product Code

JEP	Retainer, Matrix

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	2021-07-27
Device Publish Date	2021-07-19

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