OLYMPUS Winter & Ibe GmbH

Address:Berlin facility,TELTOW Brandenburg,DE

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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

Hysteroscope (And Accessories) (HIH) (10) Electrode, Electrosurgical, Active, Urological (FAS) (8) Resectoscope (FJL) (8)

Premarket Exempt

No Yes

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Olympus - 14042761085516 Catalog Number : WA22766S

Device Description : HF-resection electrode Plasma-OvalButton button, oval, 24 Fr., 12°-30°, ESG TURis

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FAS, HIH, FJL

Prescription Use : Yes

Device Count : 5

Olympus - 14042761085523 Catalog Number : WA47705S

Device Description : HF-resection electrode PlasmaLoop loop, small, 24 Fr., 12°-30°, ESG TCRis

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FAS, HIH, FJL

Prescription Use : Yes

Device Count : 5

Olympus - 14042761085615 Catalog Number : WA47740S

Device Description : HF-resection electrode PlasmaNeedle needle, right-angled, 24 Fr., 12°-30°, ESG TCRis

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FAS, HIH, FJL

Prescription Use : Yes

Device Count : 5

Olympus - 14042761085622 Catalog Number : WA47741S

Device Description : HF-resection electrode Plasma-OvalButton button, oval, long, 24 Fr., 12°-30°, ESG TCRis

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FAS, HIH, FJL

Prescription Use : Yes

Device Count : 5

Olympus - 14042761085639 Catalog Number : WA47742S

Device Description : HF-resection electrode PlasmaLoop loop, small, long, 24 Fr., 12°-30°, ESG TCRis

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FAS, HIH, FJL

Prescription Use : Yes

Device Count : 5

Olympus - 14042761085646 Catalog Number : WA47743S

Device Description : HF-resection electrode PlasmaLoop loop, large, long, 24 Fr., 12°-30°, ESG TCRis

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FAS, HIH, FJL

Prescription Use : Yes

Device Count : 5

Olympus - 14042761085653 Catalog Number : WA47744S

Device Description : HF-resection electrode PlasmaNeedle needle, long, right-angled, 24 Fr., 12°-30°, ESG TCRis

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FAS, HIH, FJL

Prescription Use : Yes

Device Count : 1404276

Olympus - 14042761085691 Catalog Number : WA47766S

Device Description : HF-resection electrode Plasma-OvalButton button, oval, 24 Fr., 12°-30°, ESG TCRis

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : FAS, HIH, FJL

Prescription Use : Yes

Device Count : 5

Olympus - 14042761086216 Catalog Number : WA47782A

Device Description : Versapoint Bipolar Electrode - Twizzle Tip 5 Fr. (1.6 mm nom.) x 360 mm

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 5

Olympus - 14042761086223 Catalog Number : WA47783A

Device Description : Versapoint Bipolar Electrode - Spring Tip 5 Fr. (1.6 mm nom.) x 360 mm

Device Class : 2

Duns Number: 316957240

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 5

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