CONVATEC, PURCHASING DEPARTMENT

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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

Catheter, Urological (KOD) (9) Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) (FCM) (9) POUCH, COLOSTOMY (EZQ) (1)

Premarket Exempt

No Yes

Clear

GENTLECATH - 04026704582471 Catalog Number : 421431

Device Description : CVT GENTLECATH CLOSED CH14

Device Class :

Duns Number: 809784593

Premarket Exempt : No

Product Code : FCM, KOD

Prescription Use : Yes

Device Count : 1

GENTLECATH - 04026704582488 Catalog Number : 421432

Device Description : CVT GENTLECATH CLOSED CH16

Device Class :

Duns Number: 809784593

Premarket Exempt : No

Product Code : FCM, KOD

Prescription Use : Yes

Device Count : 1

GENTLECATH - 04026704582495 Catalog Number : 421433

Device Description : CVT GENTLECATH CLOSED TMNN CH12

Device Class :

Duns Number: 809784593

Premarket Exempt : No

Product Code : FCM, KOD

Prescription Use : Yes

Device Count : 1

GENTLECATH - 04026704582501 Catalog Number : 421434

Device Description : 421434

Device Class :

Duns Number: 809784593

Premarket Exempt : No

Product Code : FCM, KOD

Prescription Use : Yes

Device Count : 1

GENTLECATH - 04026704582518 Catalog Number : 421435

Device Description : CVT GENTLECATH CLOSED TMNN CH16

Device Class :

Duns Number: 809784593

Premarket Exempt : No

Product Code : KOD, FCM

Prescription Use : Yes

Device Count : 1

GENTLECATH - 04026704582525 Catalog Number : 421436

Device Description : CVT GENTLECATH CLOSED RDRUB CH14

Device Class :

Duns Number: 809784593

Premarket Exempt : No

Product Code : FCM, KOD

Prescription Use : Yes

Device Count : 1

GENTLECATH - 04026704582532 Catalog Number : 421437

Device Description : CVT GENTLECATH CLOSED RDRUB CH16

Device Class :

Duns Number: 809784593

Premarket Exempt : No

Product Code : FCM, KOD

Prescription Use : Yes

Device Count : 1

GENTLECATH - 04026704582549 Catalog Number : 421438

Device Description : CVT GENTLECATH CLOSED SOFT CH14

Device Class :

Duns Number: 809784593

Premarket Exempt : No

Product Code : KOD, FCM

Prescription Use : Yes

Device Count : 1

GENTLECATH - 04026704582556 Catalog Number : 421439

Device Description : CVT GENTLECATH CLOSED FEM CH14

Device Class :

Duns Number: 809784593

Premarket Exempt : No

Product Code : FCM, KOD

Prescription Use : Yes

Device Count : 1

EUROTEC EASE - 08717905220441 Catalog Number :

Device Description : Ease® Thin Curve 3Cm X 9Cm

Device Class : 1

Duns Number: 809784593

Premarket Exempt : Yes

Product Code : EZQ

Prescription Use : No

Device Count : 1

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