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) (8) Laryngoscope, Rigid (CCW) (2)

Premarket Exempt

No Yes

Clear

SURE-SCOPE - M648C0902200 Catalog Number : C090220

Device Description : SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MILLER 2

Device Class : 1

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : Yes

Device Count : 1

SURE-SCOPE - M648C0902300 Catalog Number : C090230

Device Description : SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MILLER 3

Device Class : 1

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : CCW

Prescription Use : No

Device Count : 1

ONETRAC - M648C1001100 Catalog Number : C100110

Device Description : Retractor 135X30mm 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 - M648C1001400 Catalog Number : C100140

Device Description : C100140 ONETRAC Retractor 90x22mm 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 - M648C1001500 Catalog Number : C100150

Device Description : C100150 ONETRAC Retractor 40x20mm 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 - M648C1001650 Catalog Number :

Device Description : ONETRAC Retractor 135mmx20mm 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 - M648C1001700 Catalog Number :

Device Description : ONETRAC Retractor 55mmx8mm 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 - M648C1001800 Catalog Number :

Device Description : Retractor 105x60mm 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 - M648C1001900 Catalog Number :

Device Description : ONETRAC Retractor 175x30mm 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

ELBOW CONNECTOR - M648C1002020 Catalog Number :

Device Description : SMOKE EVACUATION TUBING CONNECTOR

Device Class : 1

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

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