OBP CORPORATION

Address:19-10 SENJU, NAKAI-CHO,,ADACHI-KU Tokyo,JP

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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

Retractor (GAD) (9) Catheter And Tip, Suction (JOL) (1)

Premarket Exempt

No Yes

Clear

ONETRAC LX - M648C1002100 Catalog Number :

Device Description : Retractor 135x30mm with Built-In Single-Use Multi-LED Light Source - STERILE

Device Class : 1

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

ONETRAC LX - M648C1002200 Catalog Number :

Device Description : Retractor 175x30mm with Built-In Single-Use Multi-LED Light Source - STERILE

Device Class : 1

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

ONETRAC LX - M648C1002300 Catalog Number :

Device Description : Retractor 90x60mm with Built-In Single-Use Multi-LED Light Source - STERILE

Device Class : 1

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

ONETRAC LX - M648C1002400 Catalog Number :

Device Description : Retractor 90x20mm with Built-In Single-Use Multi-LED Light Source - STERILE

Device Class : 1

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

ONETRAC LX - M648C1002600 Catalog Number :

Device Description : Retractor 135X60mm with Built-In Single-Use Multi-LED Light Source - STERILE

Device Class :

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

ONETRAC LXD - M648C1002700 Catalog Number :

Device Class :

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

ONETRAC LX - M648C1002800 Catalog Number :

Device Description : Retractor 90x30mm with Built-In Single-Use Multi-LED Light Source - STERILE

Device Class :

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

ONETRAC LX - M648C1002900 Catalog Number :

Device Description : Retractor 135X20mm with Built-In Single-Use Multi-LED Light Source - STERILE

Device Class :

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

ONETRAC - M648C1003000 Catalog Number :

Device Description : ONETRAC Retractor MINNESOTA with Built-In Single-Use Light Source - STERILE

Device Class : 1

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

ONETRAC LXS - M648C1102000 Catalog Number : C110200

Device Description : ONETRAC LXS SUCTION, CROWN TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE

Device Class :

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

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