ENCORE, INC.

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) (10)

Premarket Exempt

No Yes

Clear

Impoaid - 00850358007004 Catalog Number : 44010-001

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Encore - 00850358007011 Catalog Number : 44010-100

Device Description : Manual Vacuum Erection Device

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Revive - 00850358007028 Catalog Number : 44014

Device Description : Manual Vacuum Erection Device

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Revive - 00850358007035 Catalog Number : 44016-battery

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Encore - 00850358007042 Catalog Number : 44017-manual

Device Description : Manual Vacuum Erection Device

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Encore - 00850358007059 Catalog Number : 44017-battery

Device Description : Battery Vacuum Erection Device

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Revive - 00850358007066 Catalog Number : 44017-ret

Device Description : Premium Vacuum Erection Device

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Impoaid - 00850358007073 Catalog Number : 44019-001

Device Description : Battery Vacuum Erection Device

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Encore - 00850358007080 Catalog Number : 44020-001

Device Description : Vacuum Erection Device

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

Impoaid - 00850358007097 Catalog Number : 44023-001

Device Description : Ring Kit

Device Class : 2

Duns Number: 614647725

Premarket Exempt : Yes

Product Code : LKY

Prescription Use : No

Device Count : 1

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