SRS Medical Systems, Inc.

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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

Stent, Urethral, Prostatic, Semi-Permanent (NZC) (7) Device, Biofeedback (HCC) (3) Electromyograph, Diagnostic (IKN) (3)

Premarket Exempt

No Yes

Clear

The Spanner Temporary Prostatic Stent - 00890477000005 Catalog Number :

Device Class : 3

Duns Number: 796263598

Premarket Exempt : No

Product Code : NZC

Prescription Use : Yes

Device Count : 1

The Spanner Temporary Prostatic Stent - 00890477000012 Catalog Number :

Device Class : 3

Duns Number: 796263598

Premarket Exempt : No

Product Code : NZC

Prescription Use : Yes

Device Count : 1

The Spanner Temporary Prostatic Stent - 00890477000029 Catalog Number :

Device Class : 3

Duns Number: 796263598

Premarket Exempt : No

Product Code : NZC

Prescription Use : Yes

Device Count : 1

The Spanner Temporary Prostatic Stent - 00890477000036 Catalog Number :

Device Class : 3

Duns Number: 796263598

Premarket Exempt : No

Product Code : NZC

Prescription Use : Yes

Device Count : 1

The Spanner Temporary Prostatic Stent - 00890477000043 Catalog Number :

Device Class : 3

Duns Number: 796263598

Premarket Exempt : No

Product Code : NZC

Prescription Use : Yes

Device Count : 1

The Spanner Temporary Prostatic Stent - 00890477000050 Catalog Number :

Device Class : 3

Duns Number: 796263598

Premarket Exempt : No

Product Code : NZC

Prescription Use : Yes

Device Count : 1

Surveyor Urethral Measurement Device - 00890477000067 Catalog Number :

Device Class : 3

Duns Number: 796263598

Premarket Exempt : No

Product Code : NZC

Prescription Use : Yes

Device Count : 1

Insight Discovery Thermal - 00890477000074 Catalog Number :

Device Class : 2

Duns Number: 796263598

Premarket Exempt : No

Product Code : HCC, IKN

Prescription Use : Yes

Device Count : 1

Insight Discovery PWP - 00890477000081 Catalog Number :

Device Class : 2

Duns Number: 796263598

Premarket Exempt : No

Product Code : HCC, IKN

Prescription Use : Yes

Device Count : 1

Insight Discovery EMG - 00890477000098 Catalog Number :

Device Class : 2

Duns Number: 796263598

Premarket Exempt : No

Product Code : HCC, IKN

Prescription Use : Yes

Device Count : 1

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