Davol Inc.

Address:160 New Boston St,WOBURN,MA,01801,US

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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

Laparoscope, general & plastic surgery (GCJ) (6) LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) (HET) (5) APPARATUS, AUTOTRANSFUSION (CAC) (1) Agent, absorbable hemostatic, collagen based (LMF) (1) LAVAGE, JET (FQH) (1) Mesh, surgical, polymeric (FTL) (1)

Premarket Exempt

No Yes

Clear

Bard Ventralex Hernia Patch - 00801741000355 Catalog Number : 0010301

Device Description : Bard Ventralex Hernia Patch Small Circle with Strap

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Hydro-Surg - 00801741000362 Catalog Number : 0026870

Device Description : Hydro-Surg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve Hydro-Surg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33 cm Tip and Cojoined Suction and Irrigation Tubing

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Simpulse SOLO - 00801741000379 Catalog Number : 0067700

Device Description : The Simpulse SOLO System with Ultrex Retractable Splash Shield Tip

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

Avitene Flour - 00801741000386 Catalog Number : 1010020

Device Description : Avitene Microfibrillar Collagen Hemostat Flour

Device Class : 3

Duns Number: 001191048

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

SureTrans Autotransfusion System for Orthopaedics - 00801741000393 Catalog Number : 8590000

Device Description : SureTrans Autotransfusion System for Orthopaedics with PVC Drain and 2 Trocars

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : CAC

Prescription Use : No

Device Count : 1

X-Stream - 00801741010071 Catalog Number : 5552000

Device Description : X-Stream Laparoscopic Irrigation Tubing Set with SmokEvac Trumpet Valve, 5mm x 3 X-Stream Laparoscopic Irrigation Tubing Set with SmokEvac Trumpet Valve, 5mm x 33cm Probe Tip with Holes and Cojoined Suction/Irrigation Tubing

Device Class :

Duns Number: 001191048

Premarket Exempt : No

Product Code : HET, GCJ

Prescription Use : Yes

Device Count : 1

X-Stream - 00801741010088 Catalog Number : 5552001

Device Description : X-Stream Laparoscopic Irrigation Tubing Set with SmokEvac Trumpet Valve, and Coj X-Stream Laparoscopic Irrigation Tubing Set with SmokEvac Trumpet Valve, and Cojoined Suction/Irrigation Tubing, without Probe Tip

Device Class :

Duns Number: 001191048

Premarket Exempt : No

Product Code : GCJ, HET

Prescription Use : Yes

Device Count : 1

X-Stream - 00801741010095 Catalog Number : 5552002

Device Description : X-Stream Laparoscopic Irrigation Tubing Set with Nezhat-Dorsey Trumpet Valve, 5m X-Stream Laparoscopic Irrigation Tubing Set with Nezhat-Dorsey Trumpet Valve, 5mm x 33cm Probe Tip with Holes and Cojoined Suction/Irrigation Tubing

Device Class :

Duns Number: 001191048

Premarket Exempt : No

Product Code : HET, GCJ

Prescription Use : Yes

Device Count : 1

X-Stream - 00801741010101 Catalog Number : 5552003

Device Description : X-Stream Laparoscopic Irrigation Tubing Set with Nezhat-Dorsey Trumpet Valve, an X-Stream Laparoscopic Irrigation Tubing Set with Nezhat-Dorsey Trumpet Valve, and Cojoined Suction/Irrigation Tubing, without Probe Tip

Device Class :

Duns Number: 001191048

Premarket Exempt : No

Product Code : HET, GCJ

Prescription Use : Yes

Device Count : 1

X-Stream - 00801741010118 Catalog Number : 5551000

Device Description : X-Stream Laparoscopic Irrigation Controller

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : GCJ, HET

Prescription Use : Yes

Device Count : 1

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