FDA.reportPublic FDA data

SCANLAN® Instrument

Primary DI
00846159039870
Brand
SCANLAN® Instrument
Company
SCANLAN INTERNATIONAL INC
Model
Q2363-8
Catalog number
Q2363-8
Device description
Kerrison Ronguer
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159039870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159039870008461590398708461590398700846159039870

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159039672SCANLAN® Instrument3784-43N3784-43N2026-05-27
00846159039689SCANLAN® Instrument3784-44N3784-44N2026-05-27
00846159039696SCANLAN® Scissors7007-140N7007-140N2026-05-27
00846159039702SCANLAN® Scissors7007-216-1SCN7007-216-1SCN2026-05-27
00846159039719SCANLAN® Scissors7007-216-2SCN7007-216-2SCN2026-05-27
00846159039726SCANLAN® Scissors7007-401N7007-401N2026-05-27
00846159039733SCANLAN® Scissors7007-402N7007-402N2026-05-27
00846159039740SCANLAN® Scissors7007-403N7007-403N2026-05-27
00846159039757SCANLAN® Scissors7007-508N7007-508N2026-05-27
00846159039764SCANLAN® Scissors7007-509N7007-509N2026-05-27
00846159039771SCANLAN® Scissors7007-510N7007-510N2026-05-27
00846159039788SCANLAN® Instrument7506-557506-552026-05-27
00846159039795SCANLAN® Instrument8008-7008008-7002026-05-27
00846159039801SCANLAN® Instrument8008-908008-902026-05-27
00846159039818SCANLAN® ScissorsQ2108-7Q2108-72026-05-27
00846159039825SCANLAN® ScissorsQ2111-9Q2111-92026-05-27
00846159039832SCANLAN® ScissorsQ2129-7Q2129-72026-05-27
00846159039849SCANLAN® ScissorsQ2130-7Q2130-72026-05-27
00846159039856SCANLAN® ScissorsQ2325-9Q2325-92026-05-27
00846159039863SCANLAN® ForcepsQ2362-8Q2362-82026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159039788SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039795SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039801SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039818SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039825SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039832SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039849SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039856SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039863SCANLAN® ForcepsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039887SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039894SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039900SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039917SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039924SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
08022057015747JOSEPH LAMELAS Atrial Lift SystemCORCYM SRLDWS2026-02-03
08022057015754CUFF Aortic Root Exposure DeviceCORCYM SRLDWS2026-02-03
08022057015853SUTURE BELT Circumferential Suture OrganizerCORCYM SRLDWS2026-02-03
08022057015860TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureCORCYM SRLDWS2026-02-03
08022057015877JOSEPH LAMELAS Knot PusherCORCYM SRLDWS2026-02-03
G4533324301300PEAK MEDICALPeak Medical Distribution Inc.DWS2024-09-17
G586NS30105710Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G586NSCV511010Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G45352745404BC0PEAK MEDICALPeak Medical Distribution Inc.DWS2024-02-01
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