EPIMED INTERNATIONAL, INC

Address:141 SAL LANDRIO DR.,JOHNSTOWN,NY,12095,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

CATHETER, CONDUCTION, ANESTHETIC (BSO) (4) NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) (BSP) (4) Anesthesia conduction kit (CAZ) (1) Probe, radiofrequency lesion (GXI) (1)

Premarket Exempt

No Yes

Clear

Epimed - 00818788023483 Catalog Number : 301-1815

Device Description : Rulo Probe 16g x 15cm w/ 10mm Active Area No Introducer

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

Epimed - 00818788023490 Catalog Number : 108-1415

Device Description : RX Coudé® Epidural Needle with Small Bore Connection 15g RW x 3.5"

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

Epimed - 00818788023506 Catalog Number : 108-1416

Device Description : RX Coudé® Epidural Needle with Small Bore Connection 16g TW x 3.5"

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

Epimed - 00818788023513 Catalog Number : 108-1418

Device Description : RX Coudé® Epidural Needle with Small Bore Connection 18g TW x 3.5"

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

Epimed - 00818788023520 Catalog Number : 108-1516

Device Description : RX Coudé® Epidural Needle with Small Bore Connection 16g TW x 4.5"

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

Epimed - 00818788023537 Catalog Number : 153-2340

Device Description : Brevi-XL™ with Small Bore Connector 19g x 14"

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : BSO

Prescription Use : Yes

Device Count : 1

Epimed - 00818788023544 Catalog Number : 153-2540

Device Description : Tun-L-XL™ with Small Bore Connector 19g x 33.25"

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : BSO

Prescription Use : Yes

Device Count : 1

Epimed - 00818788023551 Catalog Number : 159-2112

Device Description : Versa-Kath® with Small Bore Connector 21g x 12"

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : BSO

Prescription Use : Yes

Device Count : 1

Epimed - 00818788023568 Catalog Number : 159-2124

Device Description : Versa-Kath® with Small Bore Connector 21g x 24"

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : BSO

Prescription Use : Yes

Device Count : 1

Epimed - 00818788023575 Catalog Number : 1911-419

Device Description : Nexus™ Small Bore Catheter Connector 19g

Device Class : 2

Duns Number: 799751953

Premarket Exempt : No

Product Code : CAZ

Prescription Use : Yes

Device Count : 1

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