ENCORE, INC.

Address:6487 Parkland Drive,SARASOTA,FL,34243,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

Device, External Penile Rigidity (LKY) (5)

Premarket Exempt

No Yes

Clear

Encore - 00850358007417 Catalog Number : 44017 - 3

Device Description : 44017-UNB- Vacuum Erection Device - 3 kits

Device Class : 2

Duns Number: 614647725

Premarket Exempt : No

Product Code : LKY

Prescription Use : No

Device Count : 1

Encore - 00850358007424 Catalog Number : 44017 - 3

Device Description : 44017-UNM- Vacuum Erection Device - 3 kits

Device Class : 2

Duns Number: 614647725

Premarket Exempt : No

Product Code : LKY

Prescription Use : No

Device Count : 1

Encore - 10850358007407 Catalog Number : 44017 - 12

Device Description : 44017-RETNP- Vacuum Erection Device - Master Carton 12

Device Class : 2

Duns Number: 614647725

Premarket Exempt : No

Product Code : LKY

Prescription Use : No

Device Count : 1

Encore - 10850358007414 Catalog Number : 44017 - 12

Device Description : 44017-UNB- Vacuum Erection Device - Master Carton 12

Device Class : 2

Duns Number: 614647725

Premarket Exempt : No

Product Code : LKY

Prescription Use : No

Device Count : 1

Encore - 10850358007421 Catalog Number : 44017 - 12

Device Description : 44017-UNM- Vacuum Erection Device - Master Carton 12

Device Class : 2

Duns Number: 614647725

Premarket Exempt : No

Product Code : LKY

Prescription Use : No

Device Count : 1

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