Zeus-O

GUDID 00840916156954

ZEUS-O PLASTIC DILATOR SET ACCESS PORTAL

SPINAL ELEMENTS

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00840916156954
NIH Device Record Keya7c6a9ee-165a-471f-aa5c-4abed5df4553
Commercial Distribution StatusIn Commercial Distribution
Brand NameZeus-O
Version Model Number10650-1
Company DUNS004022104
Company NameSPINAL ELEMENTS
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840916156954 [Primary]
GS100840916156954 [Primary]
GS100840916156954 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840916156954]

Moist Heat or Steam Sterilization


[00840916156954]

Moist Heat or Steam Sterilization


[00840916156954]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [Zeus-O]

00840916157197ZEUS-O DISC CUTTER KNOB
00840916157180ZEUS-O DISC CUTTER OUTER SLEEVE
00840916157173ZEUS-O DISC CUTTER INNER SHAFT
00840916156893BLADE LOCK, DISC SHAPER BODY ASSEMBLY
00840916156848ZEUS-O OUTER SHAFT
00840916156831ZEUS-O IMPLANT INSERTER OUTER SHAFT
00840916156824ZEUS-O INSERTER
00840916156817OLLIF SCOPE
00840916156800SLAP HAMMER
00840916156701ZEUS-O 9.2MM DRILL
00840916142773ZEUS-O L5-S1 ACCESS PORTAL
00840916135102VERTICAL DISC CUTTER BLADE
00840916158576OLLIF TRIAL INSERTER
00840916156978ZEUS-O ILIAC ACCESS PORTAL
00840916156961ZEUS-O ILIAC DILATOR
00840916156954ZEUS-O PLASTIC DILATOR SET ACCESS PORTAL
00840916156947ZEUS-O CURVED ROD INSERTER ASSEMBLY
00840916150990DISC SHAPER EXPANDABLE RASP

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