Davol Inc.

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

Mesh, surgical, polymeric (FTL) (2) Agent, absorbable hemostatic, non-collagen based (LMG) (1)

Premarket Exempt

No Yes

Clear

3DMax™ MID Anatomical Mesh - 00801741200786 Catalog Number : 0116321

Device Description : 3DMax™ MID Anatomical Mesh, Large, Right, 4” x 6”, 10 x 16 cm

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

3DMax™ MID Anatomical Mesh - 00801741200793 Catalog Number : 0116322

Device Description : 3DMax™ MID Anatomical Mesh, XL, Right, 5” x 7”, 12 x 17 cm

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

ARISTA™ AH FlexiTip™ - 10801741044066 Catalog Number : AM0004

Device Description : Arista AH FlexiTip Applicator

Device Class :

Duns Number: 001191048

Premarket Exempt : No

Product Code : LMG

Prescription Use : Yes

Device Count : 2

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