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

Speculum, Vaginal, Nonmetal (HIB) (6) Endoscope Channel Accessory (ODC) (4) Hysteroscope (And Accessories) (HIH) (2) Laparoscope, Gynecologic (And Accessories) (HET) (2)

Premarket Exempt

No Yes

Clear

SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN - M648C0100110 Catalog Number :

Device Description : C010011 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN (Customer REF 26153EAU/10)

Device Class : 2

Duns Number: 011560431

Premarket Exempt : No

Product Code : ODC, HIH, HET

Prescription Use : Yes

Device Count : 1

SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO - M648C0100120 Catalog Number :

Device Description : C010012 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO (Customer REF 27550ZAG/10)

Device Class : 2

Duns Number: 011560431

Premarket Exempt : No

Product Code : HET, HIH, ODC

Prescription Use : Yes

Device Count : 1

ENDOSCOPIC SEAL - M648C0100130 Catalog Number : C010013

Device Description : ENDOSCOPIC SEAL GYN 1 SIZE FITS ALL

Device Class : 2

Duns Number: 011560431

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

ENDOSCOPIC SEAL - M648C0100140 Catalog Number : C010014

Device Description : ENDOSCOPIC SEAL URO 1 SIZE FITS ALL

Device Class : 2

Duns Number: 011560431

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

OFFICESPEC - M648C0200010 Catalog Number : C020001

Device Description : SINGLE-SIDED VAGINAL SPECULUM WITH LIGHT SINGLE-USE SIZE MEDIUM

Device Class : 2

Duns Number: 011560431

Premarket Exempt : No

Product Code : HIB

Prescription Use : Yes

Device Count : 1

ER-SPEC/OFFICE-SPEC - M648C02010010 Catalog Number : C020100-1

Device Description : VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL

Device Class : 2

Duns Number: 011560431

Premarket Exempt : No

Product Code : HIB

Prescription Use : Yes

Device Count : 1

ER-SPEC/OFFICE-SPEC - M648C02011010 Catalog Number : C020110-1

Device Description : VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE MEDIUM

Device Class : 2

Duns Number: 011560431

Premarket Exempt : No

Product Code : HIB

Prescription Use : Yes

Device Count : 1

ER-SPEC/OFFICESPEC - M648C02012010 Catalog Number : C020120-1

Device Description : VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE

Device Class : 2

Duns Number: 011560431

Premarket Exempt : No

Product Code : HIB

Prescription Use : Yes

Device Count : 1

ER-SPEC/OFFICE-SPEC - M648C02013010 Catalog Number :

Device Description : VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE EXTRA SMALL

Device Class : 2

Duns Number: 011560431

Premarket Exempt : No

Product Code : HIB

Prescription Use : No

Device Count : 1

ER-SPEC - M648C02014010 Catalog Number :

Device Description : VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE EXTRA LARGE

Device Class : 2

Duns Number: 011560431

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : Yes

Device Count : 1

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