MIDMARK CORPORATION

Address:5171 California Ave,Irvine,CA,92617,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

Sterilizer, Steam (FLE) (9) CHAIR, EXAMINATION AND TREATMENT (FRK) (1)

Premarket Exempt

No Yes

Clear

Ritter - 00192965000000 Catalog Number : 95-001-216

Device Description : Not Required

Device Class : 1

Duns Number: 005036025

Premarket Exempt : Yes

Product Code : FRK

Prescription Use : No

Device Count : 1

M3 Ultrafast - 00841709100000 Catalog Number : M3-001

Device Description : The M3 UltraFast can be used in medical and dental offices, hospitals, clinics,n

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

M3 UltraFast - 00841709100017 Catalog Number : M3-002

Device Description : "The M3 UltraFast can be used in medical and dental offices, hospitals, clinics,

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Ritter M3 UltraFast - 00841709100024 Catalog Number : M3-003

Device Description : The M3 UltraFast can be used in medical and dental offices, hospitals, clinics,

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Ritter M3 UltraFast - 00841709100031 Catalog Number : M3-004

Device Description : The M3 UltraFast can be used in medical and dental offices, hospitals, clinics,

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

M9 Ultraclave - 00841709100048 Catalog Number : M9-020

Device Description : "The M9 Ultraclave can be used in medical and dental offices, hospitals, clinics

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

M9 Ultraclave - 00841709100055 Catalog Number : M9-021

Device Description : "The M9 Ultraclave can be used in medical and dental offices, hospitals, clinics

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Ritter M9 Ultraclave - 00841709100062 Catalog Number : M9-022

Device Description : "The M9 Ultraclave can be used in medical and dental offices, hospitals, clinics

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Ritter M9 Ultraclave - 00841709100079 Catalog Number : M9D-022

Device Description : The M9D Autoclave can be used in medical and dental offices, hospitals, clinics,

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

M9 Ultraclave - 00841709100086 Catalog Number : M9-020R

Device Description : "The M9 Ultraclave can be used in medical and dental offices, hospitals, clinics

Device Class : 2

Duns Number: 005036025

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

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