BIODERM, INC.

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) Solvent, Adhesive Tape (KOX) (2) Clamp, Penile (FHA) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

Yes

Clear

KindKlamp - 00653599000007 Catalog Number :

Device Description : KindKlamp, Penile Clamp

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : FHA

Prescription Use : No

Device Count : 1

BioPlus+ - 00653599000014 Catalog Number :

Device Description : BioPlus+ Wipe (box of 25)

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599000021 Catalog Number :

Device Description : Faceplate Seal 10 Pack

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

FreeDerm - 00653599000045 Catalog Number :

Device Description : FreeDerm Adhesive Remover 1 oz. Bottle

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

FreeDerm - 00653599000052 Catalog Number :

Device Description : FreeDerm Adhesive Remover 3 oz. Bottle

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

Men's Liberty Acute - 00653599000106 Catalog Number :

Device Description : Men's Liberty Acute (for Omni Medical))

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Men's Liberty Acute - 00653599000113 Catalog Number :

Device Description : Men's Liberty Acute - Canada

Device Class :

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599000168 Catalog Number :

Device Description : Men's Liberty

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599000199 Catalog Number :

Device Description : Men's Liberty Box (35 Men's Liberty and 1 FreeDerm 1 oz Spray Bottle)

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599000212 Catalog Number :

Device Description : Men's Liberty Classic

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

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