BIODERM, INC.

Address:12320 73RD COURT NORTH,LARGO,FL,33773,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, Paste-On For Incontinence, Non-Sterile (NOA) (6) Device, Intravascular Catheter Securement (KMK) (3) Clamp, Penile (FHA) (1)

Premarket Exempt

Yes

Clear

Men's Liberty - 00653599001592 Catalog Number :

Device Description : Men's Liberty, Latin America

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Men's Liberty Acute - 00653599001639 Catalog Number :

Device Description : Men's Liberty Acute - Generic or International part number, Latin America

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599001646 Catalog Number :

Device Description : Faceplate Seal 10 Pack, Latin America

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Faceplate Strip - 00653599001653 Catalog Number :

Device Description : Faceplate Strip (Pack of 10), Latin America

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

KindKlamp - 00653599001660 Catalog Number :

Device Description : KindKlamp, Penile Clamp, Latin America

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : FHA

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599001677 Catalog Number :

Device Description : Men's Liberty for iMEDicare, (pack of 10)

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599001684 Catalog Number :

Device Description : Faceplate Seal for iMEDicare (pack of 10)

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

CathGrip - 00653599001691 Catalog Number :

Device Description : CathGrip Single Strap, Small, Non-Sterile, International

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001707 Catalog Number :

Device Description : CathGrip Double Strap, Large, Non-Sterile, International

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001714 Catalog Number :

Device Description : CathGrip Double Strap, Medium, Non-Sterile, International

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

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