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

Yes No

Clear

Dornier MedTech - 00810116021802 Catalog Number : APP3515S

Device Description : PTFE Coated 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 - 00810116021826 Catalog Number : APP3815S

Device Description : PTFE Coated 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 - 00810116021840 Catalog Number : APP2515A

Device Description : PTFE Coated Guide Wire 0.025", 150cm, Angle 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 - 00810116021864 Catalog Number : APP3515A

Device Description : PTFE Coated Guide Wire 0.035", 150cm, Angle 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 - 00810116021888 Catalog Number : APP3815A

Device Description : PTFE Coated Guide Wire 0.038", 150cm, Angle 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 - 00810116021901 Catalog Number : MERI3515S

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

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116021925 Catalog Number : MERI3815S

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

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116021949 Catalog Number : MERI3515A

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

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116021963 Catalog Number : MERI3815A

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

Device Class : 1

Duns Number: 130789944

Premarket Exempt : Yes

Product Code : EYA

Prescription Use : No

Device Count : 1

Dornier MedTech - 00810116021987 Catalog Number : MERI3515SS

Device Description : PTFE/Nitinol Guide Wire 0.035", 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

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