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) (9) Urethrotome (EZO) (1)

Premarket Exempt

No Yes

Clear

Olympus - 04042761000147 Catalog Number : 00122

Device Description : Grasping forceps, 9 Fr. x 330 mm, flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000154 Catalog Number : 00123

Device Description : Biopsy forceps, 7 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000161 Catalog Number : 00124

Device Description : Biopsy forceps, 9 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000178 Catalog Number : 00125

Device Description : Grasping forceps, 9 Fr. x 330 mm, flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000185 Catalog Number : 00126

Device Description : Cannula, 7 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000208 Catalog Number : 00129

Device Description : Scissors, 9 Fr. x 330 mm, flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000277 Catalog Number : 00162

Device Description : Adapter, for bladder catheter with cone

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000284 Catalog Number : 00164

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000406 Catalog Number : 00216

Device Description : Urethrotome, acc. to Otis

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : EZO

Prescription Use : Yes

Device Count : 1

Olympus - 04042761000468 Catalog Number : 00230

Device Description : Cleaning brush, for stopcocks

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

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