42mm, 2.7mm Cortical Screw, Self-Tapping 327-1042

GUDID 00816950020858

42mm, 2.7mm Cortical Screw, Self-Tapping

Osteocentric Technologies, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00816950020858
NIH Device Record Keydd10d25f-4510-4ec4-acc0-ec6368b76f23
Commercial Distribution StatusIn Commercial Distribution
Brand Name42mm, 2.7mm Cortical Screw, Self-Tapping
Version Model Number327-1042
Catalog Number327-1042
Company DUNS089645059
Company NameOsteocentric Technologies, Inc.
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 Batchfalse
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
Emailinfo@osteocentric.com

Device Dimensions

Outer Diameter2.7 Millimeter
Length42 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950020858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950020858]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-02-19
Device Publish Date2020-06-17

Devices Manufactured by Osteocentric Technologies, Inc.

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00816950020810 - 38mm, 2.7mm Cortical Screw, Self-Tapping2024-02-19 38mm, 2.7mm Cortical Screw, Self-Tapping
00816950020834 - 40mm, 2.7mm Cortical Screw, Self-Tapping2024-02-19 40mm, 2.7mm Cortical Screw, Self-Tapping
00816950020858 - 42mm, 2.7mm Cortical Screw, Self-Tapping2024-02-1942mm, 2.7mm Cortical Screw, Self-Tapping
00816950020858 - 42mm, 2.7mm Cortical Screw, Self-Tapping2024-02-19 42mm, 2.7mm Cortical Screw, Self-Tapping
00816950020872 - 44mm, 2.7mm Cortical Screw, Self-Tapping2024-02-19 44mm, 2.7mm Cortical Screw, Self-Tapping
00816950020896 - 46mm, 2.7mm Cortical Screw, Self-Tapping2024-02-19 46mm, 2.7mm Cortical Screw, Self-Tapping
00816950020919 - 48mm, 2.7mm Cortical Screw, Self-Tapping2024-02-19 48mm, 2.7mm Cortical Screw, Self-Tapping

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