TYPENEX MEDICAL LLC

Address:303 E Wacker Dr Ste 1030,Chicago,IL,60601,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

Cassettes, Tissue (IDZ) (6) Percutaneous Sheath Introducer Kit (OFL) (4)

Premarket Exempt

No Yes

Clear

Typenex Introducer Set - 00812269033138 Catalog Number :

Device Description : 4 Fr x 30cm COAX MICRO INTRODUCER, Micro Access tip .18 Ni GW with AU tip, NON- 4 Fr x 30cm COAX MICRO INTRODUCER, Micro Access tip .18 Ni GW with AU tip, NON-MARKED, STIFF Dilator, Echo needle

Device Class : 2

Duns Number: 600850213

Premarket Exempt : No

Product Code : OFL

Prescription Use : Yes

Device Count : 1

Typenex Introducer Set - 00812269033152 Catalog Number :

Device Description : 4 Fr x 40cm COAX MICRO INTRODUCER, Micro Access tip .18 Ni GW with AU tip, NON- 4 Fr x 40cm COAX MICRO INTRODUCER, Micro Access tip .18 Ni GW with AU tip, NON-MARKED, STIFF Dilator, Echo needle

Device Class : 2

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFL

Prescription Use : Yes

Device Count : 1

Typenex Introducer Set - 00812269033763 Catalog Number :

Device Description : 6 Fr x 12 cm HV MICRO INTRODUCER, Micro Access Tip .018 Ni GW, NON-MARKED, echo needle

Device Class : 2

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFL

Prescription Use : Yes

Device Count : 1

Typenex Introducer Set - 00812269033800 Catalog Number :

Device Description : 6.5 Fr x 12 cm HV MICRO INTRODUCER, Micro Access Tip .018 Ni GW, NON-MARKED, echo needle

Device Class : 2

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : OFL

Prescription Use : Yes

Device Count : 1

Cassette Stainless Steel Base Mold - 00812269039857 Catalog Number :

Device Description : Tissue Cassette, Reusable Stainless Steel Base Mold, 7x7x7

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : IDZ

Prescription Use : No

Device Count : 1

Cassette Stainless Steel Base Mold - 00812269039864 Catalog Number :

Device Description : Stainless Steel Base Mold, 15x15x7

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : IDZ

Prescription Use : No

Device Count : 1

Cassette Stainless Steel Base Mold - 00812269039871 Catalog Number :

Device Description : Stainless Steel Base Mold, 24x24x7

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : IDZ

Prescription Use : No

Device Count : 1

Cassette Stainless Steel Base Mold - 00812269039888 Catalog Number :

Device Description : Stainless Steel Base Mold, 30x24x7

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : IDZ

Prescription Use : No

Device Count : 1

Cassette Stainless Steel Base Mold - 00812269039895 Catalog Number :

Device Description : Stainless Steel Base Mold, 37x24x7

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : IDZ

Prescription Use : No

Device Count : 1

Cassette Stainless Steel Base Mold - 00812269039901 Catalog Number :

Device Description : Stainless Steel Base Mold, 7x7x9

Device Class :

Duns Number: 600850213

Premarket Exempt : Yes

Product Code : IDZ

Prescription Use : No

Device Count : 1

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