OSTEOMED LLC

Address:3885 Arapaho Rd,ADDISON,TX,75001,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, bone (HWC) (3) DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) (HBE) (2) HANDPIECE, ROTARY BONE CUTTING (KMW) (2) PLATE, BONE (JEY) (1) SCREW, FIXATION, INTRAOSSEOUS (DZL) (1) Sterilization wrap containers, trays, cassettes & other accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

OsteoMed - 00845694098021 Catalog Number : 110-1000-SP

Device Description : Replacement Battery, Sterile

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098038 Catalog Number : 110-1000-SP-02

Device Description : Replacement Battery, Sterile, 2-Pack

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098045 Catalog Number : 110-1011

Device Description : Sterilization Container, 1 BPS

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HBE

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098052 Catalog Number : 110-1012

Device Description : Sterilization Container, 2 BPS

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HBE

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098069 Catalog Number : 110-0022

Device Description : Rigid Sterilization Container, LG

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098076 Catalog Number : 217-1603

Device Description : 1.6mm X 3.5mm Auto-Drive Screw, PC

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098083 Catalog Number : 217-1604

Device Description : 1.6mm X 4mm Auto-Drive Screw, PC

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098090 Catalog Number : 217-1605

Device Description : 1.6mm X 5mm Auto-Drive Screw, PC

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098106 Catalog Number : 217-1904

Device Description : 1.9mm x 4mm Safety Screw, PC

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098113 Catalog Number : 220-1622

Device Description : 1.6mm Driver Stem w/ Post, Medium

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 1

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