MESA LABORATORIES, INC.

Address:12100 W 6th Ave,Denver,CO,80228,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Indicator, Biological Sterilization Process (FRC) (10)

Premarket Exempt

No Yes

Clear

EZTest Steam - M985EZS61 Catalog Number : EZS/6

Device Description : self-contained biological indicator, 10e6 population, 100-count box

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 100

EZTest Steam - M985EZS6251 Catalog Number : EZS/625

Device Description : self-contained biological indicator, 10e6 population, 25-count box

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 25

EZTest Gas - M985IDEZG61 Catalog Number : IDEZG/6

Device Description : EZTest Gas self-contained biological indicator, 10e6 population, 100-count box p EZTest Gas self-contained biological indicator, 10e6 population, 100-count box printed in Italian

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 100

EZTest Steam - M985IDEZS51 Catalog Number : IDEZS/5

Device Description : self-contained biological indicator, 10e5 population, 100-count box printed in Italian

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 100

EZTest Steam - M985IDEZS61 Catalog Number : IDEZS/6

Device Description : self-contained biological indicator, 10e6 population, 100-count box printed in Italian

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 100

Smart-Read EZTest Steam - M985IDSEZS61 Catalog Number : IDSEZS/6

Device Description : self-contained biological indicator, 10e6 population, 100-count box printed in Italian

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 100

ProSpore2 - M985PS2351 Catalog Number : PS2-3-5-50

Device Description : Biological Indicator intended for steam sterilization (121C). Contains spores o Biological Indicator intended for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 50

ProSpore2 - M985PS235501 Catalog Number : PS2-3-5-50

Device Description : Self-contained biological indicator for use in steam sterilization. Log 5. 50 c Self-contained biological indicator for use in steam sterilization. Log 5. 50 count package.

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 50

ProSpore2 - M985PS2361 Catalog Number : PS2-3-6-50

Device Description : Biological Indicator for steam sterilization (121C). Contains spores of Geobaci Biological Indicator for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box.

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 50

ProSpore2 - M985PS236501 Catalog Number : PS2-3-6-50

Device Description : Self-contained biological indicator for use in steam sterilization, 10e6 populat Self-contained biological indicator for use in steam sterilization, 10e6 population, 50-count box

Device Class :

Duns Number: 102530326

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 50

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