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) (8) Device, Paste-On For Incontinence, Non-Sterile (NOA) (2)

Premarket Exempt

Yes

Clear

CathGrip - 00653599001271 Catalog Number :

Device Description : CathGrip Oval, Small, Sterile Foil Pouch

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001288 Catalog Number :

Device Description : Medline Large LVAD Securement Device, Double Strap, Sterile Foil Pouch

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001295 Catalog Number :

Device Description : Medline Medium LVAD Securement Device, Double Strap, Sterile Foil Pouch

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

Men's Liberty Acute - 00653599001301 Catalog Number :

Device Description : Men's Liberty Acute, No Wipes

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

Men's Liberty - 00653599001318 Catalog Number :

Device Description : Men's Liberty, No Wipes

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : NOA

Prescription Use : No

Device Count : 1

CathGrip - 00653599001332 Catalog Number :

Device Description : Low Profile CathGrip Double Strap, Large, Non-Sterile, No Alcohol

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001356 Catalog Number :

Device Description : CathGrip Single Strap, Small, Sterile Foil Pouch, No Wipes

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001363 Catalog Number :

Device Description : Low Profile CathGrip Double Strap, Medium, Non-Sterile, No Alcohol

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001370 Catalog Number :

Device Description : Low Profile CathGrip Single Strap, Small, Non-Sterile, No Alcohol

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

CathGrip - 00653599001387 Catalog Number :

Device Description : CathGrip Double Strap with Wing Seal, No Alcohol, Sterile

Device Class : 1

Duns Number: 114773653

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

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