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, Intravascular Catheter Securement (KMK) (7) Device, Paste-On For Incontinence, Non-Sterile (NOA) (3)

Premarket Exempt

Yes

Clear

CathGrip - 00653599001721 Catalog Number :

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

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001738 Catalog Number :

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

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001745 Catalog Number :

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

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001752 Catalog Number :

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

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001769 Catalog Number :

Device Description : CathGrip Single Strap, Large, Sterile, International

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001776 Catalog Number :

Device Description : Low Profile CathGrip Single Strap, Small, Non-Sterile

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001783 Catalog Number :

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

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599001790 Catalog Number :

Device Description : Men's Liberty for iMEDicare, (pack of 4)

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

BioDerm (Men's Liberty Acute) 4-Pack - 00653599001806 Catalog Number :

Device Description : BioDerm Men's Liberty Acute for iMEDicare

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599001813 Catalog Number :

Device Description : Men's Liberty 10-Pack Australia

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

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