3.5mm Drill Bit X 130mm, OsteoGuard 110030

GUDID 00816950025723

3.5mm Drill Bit X 130mm, OsteoGuard

SMV SCIENTIFIC LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00816950025723
NIH Device Record Keye95e41c0-645c-4932-8272-585d8d2227cc
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm Drill Bit X 130mm, OsteoGuard
Version Model Number110030
Catalog Number110030
Company DUNS089645059
Company NameSMV SCIENTIFIC LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Dimensions

Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter
Outer Diameter3.5 Millimeter
Length130 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950025723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone
HTWBit, Drill

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


[00816950025723]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-28
Device Publish Date2022-09-20

Devices Manufactured by SMV SCIENTIFIC LLC

00810074300001 - 4.0 x 12mm Screw Super Fastener, ST2023-06-20 4.0 x 12mm Screw Super Fastener, ST
00810074300018 - 4.0 x 14mm Screw Super Fastener, ST2023-06-20 4.0 x 14mm Screw Super Fastener, ST
00810074300025 - 4.0 x 16mm Screw Super Fastener, ST2023-06-20 4.0 x 16mm Screw Super Fastener, ST
00810074300032 - 4.0 x 18mm Screw Super Fastener, ST2023-06-20 4.0 x 18mm Screw Super Fastener, ST
00810074300049 - 4.0 x 20mm Screw Super Fastener, ST2023-06-20 4.0 x 20mm Screw Super Fastener, ST
00810074300056 - 4.0 x 22mm Screw Super Fastener, ST2023-06-20 4.0 x 22mm Screw Super Fastener, ST
00810074300063 - 4.0 x 24mm Screw Super Fastener, ST2023-06-20 4.0 x 24mm Screw Super Fastener, ST
00810074300070 - 4.0 x 26mm Screw Super Fastener, ST2023-06-20 4.0 x 26mm Screw Super Fastener, ST

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.