Valencia Technologies Corporation

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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

Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence (QPT) (3) General Surgery Tray (LRO) (2) Dressing Change Tray (OXQ) (1)

Premarket Exempt

No Yes

Clear

eCoin Device Kit - 00860007896903 Catalog Number : 1011-2447

Device Description : eCoin Device Kit

Device Class : 3

Duns Number: 968538988

Premarket Exempt : No

Product Code : QPT

Prescription Use : Yes

Device Count : 1

eCoin External Controller Kit - 00860007896910 Catalog Number :

Device Description : eCoin External Controller Kit

Device Class : 3

Duns Number: 968538988

Premarket Exempt : No

Product Code : QPT

Prescription Use : Yes

Device Count : 1

eCoin Procedural Kit - 00860007896927 Catalog Number :

Device Description : eCoin Procedural Kit

Device Class : 2

Duns Number: 968538988

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

eCoin Aftercare Kit - 00860007896941 Catalog Number :

Device Description : eCoin Aftercare Kit

Device Class : 1

Duns Number: 968538988

Premarket Exempt : Yes

Product Code : OXQ

Prescription Use : No

Device Count : 1

eCoin Explant Kit - 00860007896958 Catalog Number :

Device Description : eCoin Explant Kit

Device Class : 2

Duns Number: 968538988

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

eCoin Patient Kit - 00860007896965 Catalog Number :

Device Description : eCoin Patient Kit

Device Class : 3

Duns Number: 968538988

Premarket Exempt : No

Product Code : QPT

Prescription Use : Yes

Device Count : 1

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