OLYMPUS Winter & Ibe GmbH

OLYMPUS Winter & Ibe GmbH

Address:Berlin facility,TELTOW Brandenburg,DE

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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

Endoscope, Ac-Powered And Accessories (GCP) (10) Hysteroscope (And Accessories) (HIH) (1) Ureteroscope And Accessories, Flexible/Rigid (FGB) (1) Urethrotome (EZO) (1)

Premarket Exempt

No Yes

Clear

Olympus - 04042761000024 Catalog Number : 00103

Device Description : Adapter, with Luer-lock male and x-mas tree

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : EZO, FGB, HIH, GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000031 Catalog Number : 00107

Device Description : HF-electrode, button, 4 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000048 Catalog Number : 00108

Device Description : HF-electrode, button, 5 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000055 Catalog Number : 00109

Device Description : HF-electrode, button, 6 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000062 Catalog Number : 00110

Device Description : HF-electrode, button, 7 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000079 Catalog Number : 00111

Device Description : HF-electrode, button, 8 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000086 Catalog Number : 00112

Device Description : HF-electrode, button, 10 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000109 Catalog Number : 00114

Device Description : HF-electrode, needle, 5 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000116 Catalog Number : 00115

Device Description : HF-electrode, needle, 7 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000130 Catalog Number : 00121

Device Description : Grasping forceps, 7 Fr. x 330 mm, flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

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