POLYALL CURING LIGHT SLEEVE

GUDID D89260705533190

MAXILL, INC.

Medical equipment drape, single-use
Primary Device IDD89260705533190
NIH Device Record Key0cfa3115-4cf1-4cb2-84b2-fe1c1f8d4981
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOLYALL CURING LIGHT SLEEVE
Version Model Number6070553319
Company DUNS079343581
Company NameMAXILL, INC.
Device Count5000
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD89260705533190 [Unit of Use]
HIBCCD89260705533191 [Primary]
HIBCCD89260705533192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEMDental Barriers And Sleeves

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-01
Device Publish Date2022-07-22

On-Brand Devices [POLYALL CURING LIGHT SLEEVE]

D892607055331906070553319
D892607055331806070553318

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