SUNMED, LLC

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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

Stimulator, Nerve, Battery-Powered (BXN) (6) Catheter, Retention Type, Balloon (EZL) (4)

Premarket Exempt

No Yes

Clear

Sunmed - 10889483005590 Catalog Number :

Device Description : 2 Way Foley Catheter 5cc Balloon 18fr

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483005606 Catalog Number :

Device Description : 2 Way Foley Catheter 5cc Balloon 20fr

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483005613 Catalog Number :

Device Description : 2 Way Foley Catheter 5cc Balloon 22fr

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

Sunmed - 10889483005620 Catalog Number :

Device Description : 2 Way Foley Catheter 5cc Balloon 24fr

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : EZL

Prescription Use : Yes

Device Count : 1

SunMed - 10889483005835 Catalog Number :

Device Description : SunStim

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

SunMed - 10889483005842 Catalog Number :

Device Description : SunStim Plus

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

SunMed - 10889483005866 Catalog Number :

Device Description : STIM BALL ELEC X HOLLOW PIN

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

SunMed - 10889483005873 Catalog Number :

Device Description : DC 5-2014-- NO REPLACEMENT--MICRO STIM OVERLAY

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

SunMed - 10889483005941 Catalog Number :

Device Description : STIMLEADS SNAPS X SHIELDED PLUG 6'

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

SunMed - 10889483005958 Catalog Number :

Device Description : STIMLEADS CLIPS X SHIELDED PLUG 6'

Device Class : 2

Duns Number: 069009268

Premarket Exempt : No

Product Code : BXN

Prescription Use : Yes

Device Count : 1

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