SCANLAN® Instruments 8008-81N

GUDID 00846159036336

Scanlan® Loftus™ Two Level ACDF Distractor

SCANLAN INTERNATIONAL INC

Self-retaining surgical retractor, reusable
Primary Device ID00846159036336
NIH Device Record Keya52db0a0-bb32-4f1b-8776-f633f15e514e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCANLAN® Instruments
Version Model Number8008-81N
Catalog Number8008-81N
Company DUNS023055619
Company NameSCANLAN INTERNATIONAL INC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com
Phone651-298-0997
Emailvanderpoelw@scanlangroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100846159036336 [Primary]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


[00846159036336]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-10
Device Publish Date2025-01-31

On-Brand Devices [SCANLAN® Instruments]

00846159033182Micro Forceps, RH, bayo style, 1mm DD ring tips, 9"/23 cm
00846159033236Scanlan Micro Fcp, fh, bayo sty, 0.3mm str DD tips, 8-3/4"/22 cm
00846159033205Micro Forceps, RH, bayo style, 0.8mm DD tips, 9"/23 cm
00846159033199Micro Forceps, Round Handle, bayonet style, DD tips, 10"/25 cm
00846159033267Gerald Forceps, flat handle, curved tips, delicate 1x2 teeth, 7"/18 cm
00846159014921SCANLAN® Endoscopic Chitwood Knot Tier/Pusher (5mm), 30-degree angle, 5.0 suture or smaller, 12
00846159014914Endoscopic Jacobson Needle Holder, round handle, 30-degree angle, Diamond Dust™ jaws, 12.25" /
00846159036336Scanlan® Loftus™ Two Level ACDF Distractor
00846159036329Endo Fine NH, shanks curv sidew (5mm) w/rat, DD jaws, ring hdle, 12"/30.5cm
00846159036312Micro Needle Holder, RH, bayo styl, w/o rat,curv 0.3mm tap DDjaws, 9"/23cm

Trademark Results [SCANLAN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SCANLAN
SCANLAN
74389302 1837794 Live/Registered
Scanlan International, Inc.
1993-05-07
SCANLAN
SCANLAN
73625084 1439873 Live/Registered
SCANLAN INTERNATIONAL, INC.
1986-10-14

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.