Omni ARCH

GUDID 00842078121023

Omni Arch Wedge System Implant/Instrument Caddy

EXTREMITY MEDICAL, LLC

Device sterilization/disinfection container, reusable
Primary Device ID00842078121023
NIH Device Record Keycfaf4889-16da-4312-a6e8-19604f4268aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni ARCH
Version Model Number144-10004
Company DUNS832720358
Company NameEXTREMITY MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842078121023 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


[00842078121023]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-08
Device Publish Date2024-03-29

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00842078136577 - MetaFore2026-01-30 Partially Threaded Compression Screw Ø2.5 X 16, Sterile
00842078136584 - MetaFore2026-01-30 Partially Threaded Compression Screw Ø2.5 X 18, Sterile
00842078136591 - MetaFore2026-01-30 Partially Threaded Compression Screw Ø2.5 X 20, Sterile
00842078136607 - MetaFore2026-01-30 Partially Threaded Compression Screw Ø2.5 X 22, Sterile
00842078136614 - MetaFore2026-01-30 Partially Threaded Compression Screw Ø2.5 X 24, Sterile
00842078136621 - MetaFore2026-01-30 Partially Threaded Compression Screw Ø2.5 X 26, Sterile

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