N/A A-04-1

GUDID 00840239800503

XL-Shaper - Body

ADVANCED RESEARCH MEDICAL LLC

Bone curette, reusable
Primary Device ID00840239800503
NIH Device Record Keyf9614358-4fb8-4c5e-9882-e4d2c1b69185
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberA-04-1
Catalog NumberA-04-1
Company DUNS117201206
Company NameADVANCED RESEARCH 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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840239800503 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

[00840239800503]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-03
Device Publish Date2024-04-25

On-Brand Devices [N/A]

00840239800565Decorticator - Rasp
00840239800558Decorticator - Plunger
00840239800541Decorticator
00840239800534Decorticator - Dilator
00840239800404Tray Lid - Without Logo
00840239800398Tray Lid - With Logo
00840239800435Mini AO Palm Handle with Impact Cap
008402398006401/4" Square Quick Connect Ratcheting Tee Cannulated Handle
008402398005968mm Cannulated Disc Drill
00840239800688Drill Knob
00840239800619Insulating Sleeve
008402398006022.8mm Drill
00840239800589XL-Pituitary Rongeur
00840239800428XL OLLIF Tray - Basket Without Logo
00840239800466OLLIF Accessory Tray - Basket With Logo
00840239800497Instrument Platform - Handheld Scope
00840239800510XL-Shaper - Blades
00840239800701XL-Graft Delivery Tube
00840239800671XL-Flexible Curette - Outer
00840239800657XL-Graft Tamp
00840239800572Instrument Platform - Decorticator
00840239800527XL-Articulating Curette
00840239800503XL-Shaper - Body
008402398007631/4" Square QC Fixed Palm Handle
00840239800695XL-Access Portal
00840239800480Instrument Platform - Transfacet
00840239800749XL-Dilator
00840239800893Guide Wire 1.6mm X 18" Unthreaded
00840239800848Guide Wire 2.8mm X 18" Threaded
00840239800831Guide Wire 2.8mm X 10" Threaded
00840239800756XL-Disc Drill
00840239800732XL-OLLIF Inserter - Inner
00840239800725XL-OLLIF Inserter - Outer
00840239800664XL-Flexible Curette - Inner Shaft
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