Lumbar Interbody Fusion System (OLLIF) 01-14-1

GUDID 00850014575618

Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Housing

ADVANCED RESEARCH MEDICAL LLC

Neurosurgical microscope
Primary Device ID00850014575618
NIH Device Record Keybe56b008-af6a-4db7-8294-bf1dca697b0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumbar Interbody Fusion System (OLLIF)
Version Model Number01-14-1
Catalog Number01-14-1
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 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

Customer Support Contacts

Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014575618 [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

[00850014575618]

Moist Heat or Steam Sterilization

[00850014575618]

Moist Heat or Steam Sterilization

[00850014575618]

Moist Heat or Steam Sterilization

[00850014575618]

Moist Heat or Steam Sterilization

[00850014575618]

Moist Heat or Steam Sterilization

[00850014575618]

Moist Heat or Steam Sterilization

[00850014575618]

Moist Heat or Steam Sterilization

[00850014575618]

Moist Heat or Steam Sterilization

[00850014575618]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-24
Device Publish Date2021-08-16

On-Brand Devices [Lumbar Interbody Fusion System (OLLIF)]

00850014575496Lumbar Interbody Fusion System (OLLIF) Wrench
00850014575595Lumbar Interbody Fusion System (OLLIF) Inserter - Inner
00850014575489Lumbar Interbody Fusion System (OLLIF) Mallet
00850014575663Lumbar Interbody Fusion System (OLLIF) Mini AO Palm Handle
00850014575656Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Access Portal
00850014575649Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Light Guide
00850014575632Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Probe Retainer
00850014575625Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Optical Cartridge
00850014575618Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Housing
00850014575670Lumbar Interbody Fusion System (OLLIF) Pituitary Rongeur
00850014575441Lumbar Interbody Fusion System (OLLIF) Articulating Curette
00850014575366Lumbar Interbody Fusion System (OLLIF) Access Portal
00850014575403Lumbar Interbody Fusion System (OLLIF) Shaper - Blades
00850014575397Lumbar Interbody Fusion System (OLLIF) Shaper - Knob
00850014575380Lumbar Interbody Fusion System (OLLIF) Shaper - Body
00850014575731Lumbar Interbody Fusion System (OLLIF) 33 mm Implant Caddy and Lid
00850014575724Lumbar Interbody Fusion System (OLLIF) 30 mm Implant Caddy and Lid
00850014575717Lumbar Interbody Fusion System (OLLIF) 27 mm Implant Caddy and Lid
00850014575700Lumbar Interbody Fusion System (OLLIF) Case Assembly without Logo
00850014575694Lumbar Interbody Fusion System (OLLIF) Case Assembly with Logo
00850014575458Lumbar Interbody Fusion System (OLLIF) Graft Delivery Tube
00850014575540Lumbar Interbody Fusion System (OLLIF) Guide Wire - 1.4 mm X 18 in [Threaded]
00850014575762Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Light Guide Alignment Sleeve
10850014575776Lumbar Interbody Fusion System (OLLIF) Guide Wire - 1.4 mm X 18 in [Unthreaded]
00850014575687Lumbar Interbody Fusion System (OLLIF) Accessory Tray - Handheld Microscope
00850014575472Lumbar Interbody Fusion System (OLLIF) Impactor
00850014575373Lumbar Interbody Fusion System (OLLIF) Disc Drill
00850014575823Lumbar Interbody Fusion System (OLLIF) Tray - Basket Without Logo
00850014575816Lumbar Interbody Fusion System (OLLIF) Tray - Basket With Logo
00850014575809Lumbar Interbody Fusion System (OLLIF) Tray - Bottom Platform
00850014575793Lumbar Interbody Fusion System (OLLIF) Tray - Middle Platform
00850014575786Lumbar Interbody Fusion System (OLLIF) Tray - Top Platform
00850014575755Lumbar Interbody Fusion System (OLLIF) Flexible Curette Caddy and Lid
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.