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) (5) Tubes, Gastrointestinal (And Accessories) (KNT) (4) Restraint, Protective (FMQ) (1)

Premarket Exempt

No Yes

Clear

BOEHRINGER® Regulator Column/Ceiling Mount - 10816286020536 Catalog Number : 9088

Device Description : Regulator Column/Ceiling Mount

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Locking Cable - 10816286020543 Catalog Number : 9143

Device Description : Locking Cable

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Pipe Nipple 1/8" X 1 1/2 - 10816286020550 Catalog Number : 33291

Device Description : Pipe Nipple 1/8" X 1 1/2

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Arm Restraint Straps ( 1 pair ) - 27 Inches - 10816286020567 Catalog Number : 9008

Device Description : Arm Restraint Straps ( 1 pair ) - 27 Inches

Device Class :

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : FMQ

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Suction Regulator, Continuous, 0-200, off/reg/line - 10816286020574 Catalog Number : 7800

Device Description : Suction Regulator, Continuous, 0-200, off/reg/line

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® Suction Regulator, Intermittent/Continuous, 0-200, off/reg/line - 10816286020581 Catalog Number : 7804

Device Description : Suction Regulator, Intermittent/Continuous, 0-200, off/reg/line

Device Class : 2

Duns Number: 079991657

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

BOEHRINGER® ViSiGi 3D™ Calibration System for Roux-en-y, size 32Fr - 10816286020598 Catalog Number :

Device Description : ViSiGi 3D® Calibration System size 32Fr Sleeve/Std

Device Class :

Duns Number: 079991657

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr - 10816286020604 Catalog Number :

Device Description : ViSiGi 3D® Calibration System size 36Fr Sleeve/Std

Device Class :

Duns Number: 079991657

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

BOEHRINGER® ViSiGi™ 3D Sleeve Gastrectomy Calibration System, size 40Fr - 10816286020611 Catalog Number :

Device Description : ViSiGi 3D® Calibration System size 40Fr Sleeve/Std

Device Class :

Duns Number: 079991657

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

BOEHRINGER® ViSiGi 3D™ Calibration System for Roux-en-y, size 32Fr w/bulb - 10816286020628 Catalog Number :

Device Description : ViSiGi 3D® Calibration System size 32Fr Std w/ Bulb

Device Class :

Duns Number: 079991657

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

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