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

Replacement, Ossicular Prosthesis, Total (ETA) (10)

Premarket Exempt

Yes No

Clear

Total Middle Ear Implant - 04250381803882 Catalog Number : 11300

Device Description : Total middle ear implant, shortenable, titanium, with head, 7.5x0.3 mm, sterile, 1 piece

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

Total Middle Ear Implant - 04250381803899 Catalog Number : 11400

Device Description : Total middle ear implant, shortenable, titanium, with head, 7.0x0.3 mm, sterile, 1 piece

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

Total Middle Ear Implant - 04250381803912 Catalog Number : 11500

Device Description : Total middle ear implant, shortenable, titanium, with shoe, adjustable, 7.8x0.4 Total middle ear implant, shortenable, titanium, with shoe, adjustable, 7.8x0.4 mm, sterile, 1 piece

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

Total Middle Ear Implant - 04250381803943 Catalog Number : 11600

Device Description : Total middle ear implant, shortenable, titanium, with shoe, adjustable, 7.3x0.4 Total middle ear implant, shortenable, titanium, with shoe, adjustable, 7.3x0.4 mm, sterile, 1 piece

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

Total Middle Ear Implant - 04250381804025 Catalog Number : 11835

Device Description : Total middle ear implant, fixed size, titanium, oval-excentric head, 3.5x0.3 mm, Total middle ear implant, fixed size, titanium, oval-excentric head, 3.5x0.3 mm, sterile, 1 piece

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

Total Middle Ear Implants - 04250381804032 Catalog Number : 11840

Device Description : Total middle ear implant, fixed size, titanium, oval-excentric head, 4.0x0.3 mm, Total middle ear implant, fixed size, titanium, oval-excentric head, 4.0x0.3 mm, sterile, 1 piece

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

Total Middle Ear Implant - 04250381804179 Catalog Number : 11870

Device Description : Total middle ear implant, fixed size, titanium, oval-excentric head, 7.0x0.3 mm, Total middle ear implant, fixed size, titanium, oval-excentric head, 7.0x0.3 mm, sterile, 1 piece

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

Total Middle Ear Implant - 04250381804230 Catalog Number : 11945

Device Description : Total middle ear implant, fixed size, titanium, round-centric head, 4.5x0.3 mm, Total middle ear implant, fixed size, titanium, round-centric head, 4.5x0.3 mm, sterile, 1 piece

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

Total Middle Ear Implant - 04250381804261 Catalog Number : 11955

Device Description : Total middle ear implant, fixed size, titanium round-centric head, 5.5x0.3 mm, sterile

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

Total Middle Ear Implant - 04250381804278 Catalog Number : 11960

Device Description : Total middle ear implant, fixed size, titanium, round-centric head, 6.0x0.3 mm, Total middle ear implant, fixed size, titanium, round-centric head, 6.0x0.3 mm, sterile, 1 piece

Device Class : 2

Duns Number: 332893028

Premarket Exempt : No

Product Code : ETA

Prescription Use : Yes

Device Count : 1

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