DIAMOND ORTHOPEDIC, LLC

Address:1669 Federal Ave,Gastonia,NC,28052,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

Bit, Drill (HTW) (2) Guide, Surgical, Instrument (FZX) (2) Orthopedic Manual Surgical Instrument (LXH) (2) Screwdriver (HXX) (2) Countersink (HWW) (1) Gauge, Depth (HTJ) (1)

Premarket Exempt

Yes

Clear

Diamond Orthopedic, LLC - B551DMD310215 Catalog Number : DMD-310-215

Device Description : Drill bit - 1.7mm cannulated, 100mm long

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

Diamond Orthopedic, LLC - B551DMD310221 Catalog Number : DMD-310-221

Device Description : Drill bit - 2.0mm cannulated, 150mm long

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

Diamond Orthopedic, LLC - B551DMD310803 Catalog Number : DMD-310-803

Device Description : Countersink - cannulated, for 2.4mm cannulated screws

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : HWW

Prescription Use : No

Device Count : 1

Diamond Orthopedic, LLC - B551DMD311430 Catalog Number : DMD-311-430

Device Description : Handle with quick-coupling

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

Diamond Orthopedic, LLC - B551DMD312145 Catalog Number : DMD-312-145

Device Description : Drill Sleeve - 0.8/1.7mm, double

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

Diamond Orthopedic, LLC - B551DMD312151 Catalog Number : DMD-312-151

Device Description : Drill Sleeve - 1.1/2.0mm, double

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

Diamond Orthopedic, LLC - B551DMD314466 Catalog Number : DMD-314-466

Device Description : Screwdriver Shaft - T8, cannulated with quick coupling

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

Diamond Orthopedic, LLC - B551DMD319292 Catalog Number : DMD-319-292

Device Description : Cleaning Stylet - 1.1mm, Length 150mm

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Diamond Orthopedic, LLC - B551DMD319293 Catalog Number : DMD-319-293

Device Description : Cleaning Stylet - 0.8mm, Length 150mm

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Diamond Orthopedic, LLC - B551DMD319703 Catalog Number : DMD-319-703

Device Description : Measuring Device - 100mm

Device Class : 1

Duns Number: 080596041

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : No

Device Count : 1

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