DORNIER MEDTECH AMERICA, INC.

Address:1155 ROBERTS BLVD.,KENNESAW,GA,30144,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

Stylet, Ureteral (EYA) (10)

Premarket Exempt

No Yes

Clear

Dornier MedTech - 00810116022007 Catalog Number : MERI3815SS

Device Description : PTFE/Nitinol Guide Wire 0.038", 150cm, Straight 3cm tip, flexible both ends, Super Stiff

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022021 Catalog Number : MERI3515AS

Device Description : PTFE/Nitinol Guide Wire 0.035", 150cm, Angle 3cm tip, flexible both ends, Super Stiff

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022045 Catalog Number : MERI3815AS

Device Description : PTFE/Nitinol Guide Wire 0.038", 150cm, Angle 3cm tip, flexible both ends, Super Stiff

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022069 Catalog Number : SLIP3515S

Device Description : Nitinol Hydrophilic Guide Wire 0.035", 150cm, Straight, 3cm tip, flexible one en Nitinol Hydrophilic Guide Wire 0.035", 150cm, Straight, 3cm tip, flexible one end, regular stiffness

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022083 Catalog Number : SLIP3815S

Device Description : Nitinol Hydrophilic Guide Wire 0.038", 150cm, Straight, 3cm tip, flexible one en Nitinol Hydrophilic Guide Wire 0.038", 150cm, Straight, 3cm tip, flexible one end, regular stiffness

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022106 Catalog Number : SLIP3515A

Device Description : Nitinol Hydrophilic Guide Wire 0.035", 150cm, Angled, 3cm tip, flexible one end, Nitinol Hydrophilic Guide Wire 0.035", 150cm, Angled, 3cm tip, flexible one end, regular stiffness

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022120 Catalog Number : SLIP3815A

Device Description : Nitinol Hydrophilic Guide Wire 0.038", 150cm, Angled, 3cm tip, flexible one end, Nitinol Hydrophilic Guide Wire 0.038", 150cm, Angled, 3cm tip, flexible one end, regular stiffness

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022144 Catalog Number : SLIP3515SS

Device Description : Nitinol Hydrophilic Guide Wire 0.035", 150cm, Straight, 3cm tip, flexible one end, Stiff

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022168 Catalog Number : SLIP3815SS

Device Description : Nitinol Hydrophilic Guide Wire 0.038", 150cm, Straight, 3cm tip, flexible one end, Stiff

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116022182 Catalog Number : SLIP3515AS

Device Description : Nitinol Hydrophilic Guide Wire 0.035", 150cm, Angled, 3cm tip, flexible one end, Stiff

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

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