PHOSPHOR PLATE BARRIER ENVELOPES

GUDID D89260705533650

MAXILL, INC.

Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette

Primary Device ID	D89260705533650
NIH Device Record Key	d59b2cc9-6bb3-424b-af57-a99c75b71fb0
Commercial Distribution Status	In Commercial Distribution
Brand Name	PHOSPHOR PLATE BARRIER ENVELOPES
Version Model Number	6070553365
Company DUNS	079343581
Company Name	MAXILL, INC.
Device Count	10000
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D89260705533650 [Unit of Use]
HIBCC	D89260705533651 [Primary]
HIBCC	D89260705533652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163447

FDA Product Code

PEM	Dental Barriers And Sleeves

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	2022-08-01
Device Publish Date	2022-07-22

On-Brand Devices [PHOSPHOR PLATE BARRIER ENVELOPES]

D89260705533670	6070553367
D89260705533660	6070553366
D89260705533650	6070553365
D89260705533620	6070553362
D89260705533610	6070553361
D89260705533600	6070553360