Omnia Medical Golden Spike OM-TLS4038

GUDID 00843511100810

4.0 x 38mm Trauma Screw

OMNIA MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00843511100810
NIH Device Record Key7bff987d-f296-4858-931a-967dba153fe8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical Golden Spike
Version Model NumberOM-TLS4038
Catalog NumberOM-TLS4038
Company DUNS079467378
Company NameOMNIA MEDICAL, 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

Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com

Device Dimensions

Outer Diameter4 Millimeter
Length38 Millimeter
Outer Diameter4 Millimeter
Length38 Millimeter
Outer Diameter4 Millimeter
Length38 Millimeter
Outer Diameter4 Millimeter
Length38 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511100810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511100810]

Moist Heat or Steam Sterilization


[00843511100810]

Moist Heat or Steam Sterilization


[00843511100810]

Moist Heat or Steam Sterilization


[00843511100810]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-15
Device Publish Date2020-05-07

On-Brand Devices [Omnia Medical Golden Spike ]

008435111008724.0 x 50mm Trauma Screw
008435111008654.0 x 48mm Trauma Screw
008435111008584.0 x 46mm Trauma Screw
008435111008414.0 x 44mm Trauma Screw
008435111008344.0 x 42mm Trauma Screw
008435111008274.0 x 40mm Trauma Screw
008435111008104.0 x 38mm Trauma Screw
008435111008034.0 x 36mm Trauma Screw
008435111007974.0 x 34mm Trauma Screw
008435111007804.0 x 32mm Trauma Screw
008435111007734.0 x 30mm Trauma Screw
008435111007664.0 x 28mm Trauma Screw
008435111007594.0 x 26mm Trauma Screw
00843511121761Screw inserter
008435111230174.0 x 50mm Threaded Trauma Screw
008435111230004.0 x 48mm Threaded Trauma Screw
008435111229974.0 x 46mm Threaded Trauma Screw
008435111229804.0 x 44mm Threaded Trauma Screw
008435111229734.0 x 42mm Threaded Trauma Screw
008435111229664.0 x 40mm Threaded Trauma Screw
008435111229594.0 x 38mm Threaded Trauma Screw
008435111229424.0 x 36mm Threaded Trauma Screw
008435111229354.0 x 34mm Threaded Trauma Screw
008435111229284.0 x 32mm Threaded Trauma Screw
008435111229114.0 x 30mm Threaded Trauma Screw
008435111229044.0 x 28mm Threaded Trauma Screw
008435111228984.0 x 26mm Threaded Trauma Screw
00843511122867Threaded Screw Inserter
00843511122843Split Tip Inserter
00843511123208Threaded TLS Screw Inserter - AO Connection

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