Spiggle & Theis Medizintechnik GmbH

Address:Burghof 14,OVERATH North Rhine-Westphalia,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

TRAY, SURGICAL, ENT (MMO) (6) BLADE, SCALPEL (GES) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1) Spectacle microscope, low-vision (HKC) (1)

Premarket Exempt

No Yes

Clear

Bipolar Forceps - 00425038188788 Catalog Number : 80-111-16

Device Description : Bipolar forceps, NON-STICK, bayonet, tip length 8 mm, 1.0 mm wide, guide pin, 16 cm

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Endoscope container with lid, stainless - 04044593003365 Catalog Number : 80-691-01

Device Description : steel, e-polished, for 1 endoscope, 460x80x52 mm

Device Class : 1

Duns Number: 332893028

Premarket Exempt : Yes

Product Code : MMO

Prescription Use : Yes

Device Count : 1

Endoscope container with lid, stainless - 04044593003402 Catalog Number : 80-690-01

Device Description : steel, e-polished, for 1 endoscope 290x80x52 mm

Device Class : 1

Duns Number: 332893028

Premarket Exempt : Yes

Product Code : MMO

Prescription Use : Yes

Device Count : 1

Endoscope container with lid, stainless - 04044593003419 Catalog Number : 80-692-01

Device Description : steel, e-polished, for 1 endoscope 670x80x52 mm

Device Class : 1

Duns Number: 332893028

Premarket Exempt : Yes

Product Code : MMO

Prescription Use : Yes

Device Count : 1

Endoscope container with lid, stainless - 04044593003747 Catalog Number : 80-690-02

Device Description : steel, e-polished, for 2 endoscopes 290x80x52 mm

Device Class : 1

Duns Number: 332893028

Premarket Exempt : Yes

Product Code : MMO

Prescription Use : Yes

Device Count : 1

ENT instrument tray, 480x250x40 mm - 04044593004355 Catalog Number : 80-695-00

Device Description : stainless steel with removable lid,smallparts basket and instrument holders

Device Class : 1

Duns Number: 332893028

Premarket Exempt : Yes

Product Code : MMO

Prescription Use : Yes

Device Count : 1

Scalpel blades - 04048614010127 Catalog Number : 10-360-10

Device Description : no. 10, single sterile packed 100 pieces

Device Class : 1

Duns Number: 332893028

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

Scalpel blades - 04048614010134 Catalog Number : 10-360-11

Device Description : no. 11, single sterile packed 100 pieces

Device Class : 1

Duns Number: 332893028

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

3/4 storage- and cleaning tray with lid - 04049224311970 Catalog Number : 80-250-00

Device Description : stainless steel 405x255x75 mm

Device Class : 1

Duns Number: 332893028

Premarket Exempt : Yes

Product Code : MMO

Prescription Use : Yes

Device Count : 1

Brünings loupe head - 04050659354517 Catalog Number : 10-182-04

Device Description : closed, without magnification

Device Class : 1

Duns Number: 332893028

Premarket Exempt : Yes

Product Code : HKC

Prescription Use : Yes

Device Count : 1

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