Instrument Set

GUDID D9498000112

Convenience kit of Bioclear products used in dental restorations.

Bioclear Matrix Systems

Manual non-rotary dental instrument handle
Primary Device IDD9498000112
NIH Device Record Keyd94429a7-dae7-4631-9992-aaa0a58cf6f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstrument Set
Version Model NumberElite
Company DUNS059020838
Company NameBioclear Matrix Systems
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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
HIBCCD9498000112 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


[D9498000112]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-18
Device Publish Date2023-08-10

On-Brand Devices [Instrument Set]

D9498000212Convenience kit of Bioclear products used in dental restorations.
D9498000112Convenience kit of Bioclear products used in dental restorations.
D9498000213Convenience kit of Bioclear products used in dental restorations.

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