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

LAVAGE, JET (FQH) (10)

Premarket Exempt

No Yes

Clear

Simpulse - 00801741010248 Catalog Number : 0067740

Device Description : Femoral Canal Tip

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

Simpulse - 00801741010255 Catalog Number : 0067750

Device Description : Femoral Canal Tip - Irrigation Only

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

Simpulse - 00801741010262 Catalog Number : 0067910

Device Description : Femoral Canal Brush with Suction and Irrigation

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

Simpulse - 00801741010279 Catalog Number : 0067621

Device Description : Showerhead Tip

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

ULTREX - 00801741010309 Catalog Number : 0067710

Device Description : ULTREX Retractable Small Splash Shield Tip

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

ULTREX - 00801741010316 Catalog Number : 0067720

Device Description : ULTREX Retractable Splash Shield Tip

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

Simpulse - 00801741010323 Catalog Number : 0067730

Device Description : Soft Splash Shield Tip

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

Simpulse - 00801741010330 Catalog Number : 0037630

Device Description : Simpulse Suction Irrigator Splash Shield

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

Simpulse - 00801741010347 Catalog Number : 0037640

Device Description : Simpulse Suction Irrigator Splash Shield

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

Simpulse - 00801741010354 Catalog Number : 0037690

Device Description : Dual Spike Adapter

Device Class : 2

Duns Number: 001191048

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

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