3.3mm Locking Drill Guide 317-0019

GUDID 00816950029509

3.3mm Locking Drill Guide

SMV SCIENTIFIC LLC

Surgical drill guide, reusable
Primary Device ID00816950029509
NIH Device Record Key2240f963-8276-40a3-a306-c6c36714e3a9
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.3mm Locking Drill Guide
Version Model Number317-0019
Catalog Number317-0019
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

Device Dimensions

Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter
Outer Diameter3.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950029509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


[00816950029509]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-17
Device Publish Date2021-05-07

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.