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

Laparoscope, General & Plastic Surgery (GCJ) (4) Endoscope, Ac-Powered And Accessories (GCP) (3) Laparoscope, Gynecologic (And Accessories) (HET) (2) Resectoscope (FJL) (2) Electrode, Electrosurgical, Active, Urological (FAS) (1) Forceps, Biopsy, Electric (KGE) (1)

Premarket Exempt

No Yes

Clear

Olympus - 04042761001113 Catalog Number : A0275

Device Description : HF-electrode, button, 9 Fr., flexible

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761001465 Catalog Number : A0335.1

Device Description : HF-cable, monopolar, 3.5 m, UES-30, Erbe Intl. and Valleylab (new) HF-unit to 3 HF-cable, monopolar, 3.5 m, UES-30, Erbe Intl. and Valleylab (new) HF-unit to 3 mm pin surgical instrument

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : KGE

Prescription Use : Yes

Device Count : 1

Olympus - 04042761001472 Catalog Number : A0336.1

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FJL, FAS

Prescription Use : Yes

Device Count : 1

Olympus - 04042761001533 Catalog Number : A0355

Device Description : HF-cable, monopolar, 3.5 m, UES-10/20 and Valleylab (old) HF-unit to HiQ, HiQ+

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP, HET

Prescription Use : Yes

Device Count : 1

Olympus - 04042761001540 Catalog Number : A0357

Device Description : HF cable, monopolar, 3.5 m, Martin and Berchtold HF-unit to HiQ, HiQ+

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCP

Prescription Use : Yes

Device Count : 1

Olympus - 04042761001557 Catalog Number : A0358

Device Description : HF-cable, monopolar, 3.5 m, UES-30, Erbe Intl. and Valleylab (new) HF-unit to HiQ, HiQ+

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCJ, HET

Prescription Use : Yes

Device Count : 1

Olympus - 04042761001632 Catalog Number : A0391

Device Description : HF-cable, monopolar, 4 m, UES-10/20 and Valleylab (old) HF-unit to resectoscope

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Olympus - 04042761001649 Catalog Number : A0392

Device Description : HF-cable, monopolar, 4 m, Martin and Berchtold HF-unit to resectoscope

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Olympus - 04042761001656 Catalog Number : A0393

Device Description : HF-cable, monopolar, 4 m, UES-30/-40, Erbe Intl. and Valleylab (new) HF-unit to HF-cable, monopolar, 4 m, UES-30/-40, Erbe Intl. and Valleylab (new) HF-unit to resectoscope

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Olympus - 04042761001823 Catalog Number : A0418

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FJL

Prescription Use : Yes

Device Count : 1

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