Lumbar Interbody Fusion System (OLLIF) Oblique 33 mm Implants in Caddy O-3300

GUDID 00850014575342

Lumbar Interbody Fusion System (OLLIF) Oblique 33 mm Implants in Caddy

ADVANCED RESEARCH MEDICAL LLC

Instrument tray
Primary Device ID00850014575342
NIH Device Record Key5c6761dd-6d5c-4710-8341-8b8c7e937b97
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumbar Interbody Fusion System (OLLIF) Oblique 33 mm Implants in Caddy
Version Model NumberO-3300
Catalog NumberO-3300
Company DUNS117201206
Company NameADVANCED RESEARCH MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com
Phone(612)440-1865
Emailinfo@advresmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014575342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


[00850014575342]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-24
Device Publish Date2019-12-16

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00840239800732 - N/A2025-06-12 XL-OLLIF Inserter - Inner
00840239800756 - N/A2025-06-12 XL-Disc Drill
00840239800831 - N/A2025-06-12 Guide Wire 2.8mm X 10" Threaded
00840239800848 - N/A2025-06-12 Guide Wire 2.8mm X 18" Threaded
00840239800893 - N/A2025-06-12 Guide Wire 1.6mm X 18" Unthreaded
00840239800749 - N/A2025-05-09 XL-Dilator

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