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

Catheter, Suprapubic (And Accessories) (KOB) (6) Endoscope, Ac-Powered And Accessories (GCP) (2) Ureteroscope And Accessories, Flexible/Rigid (FGB) (2)

Premarket Exempt

No Yes

Clear

Olympus - 04042761002332 Catalog Number : A0559

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761002943 Catalog Number : A2246

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Olympus - 04042761002950 Catalog Number : A2247

Device Description : Insertion sleeve, for suprapubic overflow controller

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Olympus - 04042761002967 Catalog Number : A2248

Device Description : Trocar spike, for suprapubic overflow controller

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Olympus - 04042761002974 Catalog Number : A2249

Device Description : Suction tube, for suprapubic overflow controller

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Olympus - 04042761002981 Catalog Number : A2250

Device Description : Overflow tube, for suprapubic overflow controller

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Olympus - 04042761002998 Catalog Number : A2251

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Olympus - 04042761003308 Catalog Number : A2421

Device Description : Grasping forceps, toothed, 5 Fr. x 640 mm, flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FGB

Prescription Use : Yes

Device Count : 1

Olympus - 04042761003315 Catalog Number : A2422

Device Description : Grasping forceps, rat tooth, 5 Fr. x 640 mm, flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761003322 Catalog Number : A2423

Device Description : Biopsy forceps, 5 Fr. x 640 mm, flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FGB

Prescription Use : Yes

Device Count : 1

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