Impladent, Ltd.

Address:86-90 188 STREET,HOLLIS,NY,11423,US

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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

Screw, Fixation, Intraosseous (DZL) (8)

Premarket Exempt

Clear

TriStar Screws - 8mm (Pack of 5) - 00855286006174 Catalog Number :

Device Description : Pack of 5 Ti-Alloy Screws, Length: 8mm total, 5mm threaded, 3mm unthreaded

Device Class : 2

Duns Number: 199838400

Premarket Exempt : No

Product Code : DZL

Prescription Use : No

Device Count : 1

TriStar Screws - 10mm (Pack of 5) - 00855286006181 Catalog Number :

Device Description : Pack of 5 Ti-Alloy Screws, Length: 10mm total, 5mm threaded, 5mm unthreaded

Device Class : 2

Duns Number: 199838400

Premarket Exempt : No

Product Code : DZL

Prescription Use : No

Device Count : 1

TriStar Screws - 12mm (Pack of 5) - 00855286006198 Catalog Number :

Device Description : Pack of 5 Ti-Alloy Screws, Length: 12mm total, 6mm threaded, 6mm unthreaded

Device Class : 2

Duns Number: 199838400

Premarket Exempt : No

Product Code : DZL

Prescription Use : No

Device Count : 1

TriStar Screws - 14mm (Pack of 5) - 00855286006204 Catalog Number :

Device Description : Pack of 5 Ti-Alloy Screws, Length: 14mm total, 7mm threaded, 7mm unthreaded

Device Class : 2

Duns Number: 199838400

Premarket Exempt : No

Product Code : DZL

Prescription Use : No

Device Count : 1

TriStar Screws - 15mm (Pack of 5) - 00855286006211 Catalog Number :

Device Description : Pack of 5 Ti-Alloy Screws, Length: 15mm total, Fully Threaded

Device Class : 2

Duns Number: 199838400

Premarket Exempt : No

Product Code : DZL

Prescription Use : No

Device Count : 1

TriStar Screws - 18mm (Pack of 5) - 00855286006228 Catalog Number :

Device Description : Pack of 5 Ti-Alloy Screws, Length: 18mm total, Fully Threaded

Device Class : 2

Duns Number: 199838400

Premarket Exempt : No

Product Code : DZL

Prescription Use : No

Device Count : 1

TriStar Screws - 21mm (Pack of 5) - 00855286006235 Catalog Number :

Device Description : Pack of 5 Ti-Alloy Screws, Length: 21mm total, Fully Threaded

Device Class : 2

Duns Number: 199838400

Premarket Exempt : No

Product Code : DZL

Prescription Use : No

Device Count : 1

TriStar Screws - 24mm (Pack of 5) - 00855286006242 Catalog Number :

Device Description : Pack of 5 Ti-Alloy Screws, Length: 24mm total, Fully Threaded

Device Class : 2

Duns Number: 199838400

Premarket Exempt : No

Product Code : DZL

Prescription Use : No

Device Count : 1

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