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

Collagen surgical mesh containing drugs (PIJ) (6) Mesh, surgical (FTM) (6) Mesh, surgical, collagen, plastic and reconstructive surgery (OXH) (6) Laparoscope, general & plastic surgery (GCJ) (4) Mesh, surgical, deployer (ORQ) (4) Mesh, surgical, polymeric (FTL) (4)

Premarket Exempt

Yes No

Clear

XenMatrix AB Surgical Graft - 00801741128998 Catalog Number : 1151530

Device Description : XenMatrix AB Surgical Graft

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : PIJ, OXH, FTM

Prescription Use : Yes

Device Count : 1

XenMatrix AB Surgical Graft - 00801741129001 Catalog Number : 1152040

Device Description : XenMatrix AB Surgical Graft

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : OXH, FTM, PIJ

Prescription Use : Yes

Device Count : 1

XenMatrix AB Surgical Graft - 00801741129018 Catalog Number : 1152530

Device Description : XenMatrix AB Surgical Graft

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FTM, OXH, PIJ

Prescription Use : Yes

Device Count : 1

XenMatrix AB Surgical Graft - 00801741129025 Catalog Number : 1152540

Device Description : XenMatrix AB Surgical Graft

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : PIJ, FTM, OXH

Prescription Use : Yes

Device Count : 1

XenMatrix AB Surgical Graft - 00801741129032 Catalog Number : 1153030

Device Description : XenMatrix AB Surgical Graft

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : PIJ, FTM, OXH

Prescription Use : Yes

Device Count : 1

XenMatrix AB Surgical Graft - 00801741129049 Catalog Number : 1153045

Device Description : XenMatrix AB Surgical Graft

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : OXH, FTM, PIJ

Prescription Use : Yes

Device Count : 1

Ventralight ST Mesh with ECHO 2 Positioning System - 00801741130977 Catalog Number : 5990011

Device Description : Ventralight ST Mesh with ECHO 2 Positioning System 11 cm (4.5)" Circle

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : GCJ, ORQ, FTL

Prescription Use : Yes

Device Count : 1

Ventralight ST Mesh with ECHO 2 Positioning System - 00801741130984 Catalog Number : 5991015

Device Description : Ventralight ST Mesh with ECHO 2 Positioning System 10 cm x 15 cm (4" x 6") Ellipse

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FTL, GCJ, ORQ

Prescription Use : Yes

Device Count : 1

Ventralight ST Mesh with Echo 2 Positioning - 00801741130991 Catalog Number : 5990015

Device Description : Ventralight™ ST Mesh with Echo 2™ Positioning System15 cm / 6“ Circle

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FTL, ORQ, GCJ

Prescription Use : Yes

Device Count : 1

Ventralight ST Mesh with ECHO 2 Positioning System - 00801741131004 Catalog Number : 5991520

Device Description : Ventralight™ ST Mesh with Echo 2™ Positioning System15cm x 20cm / 6“ x 8“ Ellipse

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : ORQ, GCJ, FTL

Prescription Use : Yes

Device Count : 1

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