BOEHRINGER LABORATORIES, LLC

Address:300 Thoms Drive,Phoenixville,PA,19460,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

Regulator, Vacuum (KDP) (7) Tubes, Gastrointestinal (And Accessories) (KNT) (3)

Premarket Exempt

No Yes

Clear

BOEHRINGER® ViSiGi 3D™ Low Suction Sleeve Gastrectomy Calibration Sys, size 36Fr - 10816286020734 Catalog Number : 5236LS

Device Description : ViSiGi 3D™ Low Suction Sleeve Gastrectomy Calibration System, size 36Fr

Device Class : 2

Duns Number: 079991657

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

BOEHRINGER® ViSiGi 3D™ Low Suction Sleeve Gastrectomy Calibration Sys, size 40Fr - 10816286020741 Catalog Number : 5240LS

Device Description : ViSiGi™ 3D Low Suction Sleeve Gastrectomy Calibration System, size 40Fr

Device Class : 2

Duns Number: 079991657

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Regulator Washer - 10816286020758 Catalog Number : 7992

Device Description : Regulator Washer

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Replacement Plastic Bottle for 9101 Trap - 10816286020765 Catalog Number : 34059

Device Description : Replacement Plastic Bottle for 9101 Trap

Device Class :

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Replacement Vacuum Valve for 9101 Trap - 10816286020772 Catalog Number : 34045

Device Description : Replacement Vacuum Valve for 9101 Trap

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Lens Cap for 3800 Series, Colored Blush Pink - 10816286020789 Catalog Number : 9070

Device Description : Lens Cap for 3800 Series, Colored Blush Pink

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Lens Cap for 3800 Series, Colored Baby Blue - 10816286020796 Catalog Number : 9076

Device Description : Lens Cap for 3800 Series, Colored Baby Blue

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® VAVD VacPac - 10816286020802 Catalog Number : 3948

Device Description : VAVD VacPac

Device Class :

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® VAVD Adapter Assembly - 10816286020819 Catalog Number : 3945

Device Description : VAVD Adapter Assembly

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® ViSiGi 3D® Calibration System size 32Fr Bypass/Short - 10816286020826 Catalog Number :

Device Description : ViSiGi 3D® Calibration System size 32Fr Bypass/Short

Device Class :

Duns Number: 079991657

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

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