FDA.reportPublic FDA data

SCANLAN® Easy-Tag™ Tracking System

Primary DI
00846159033045
Brand
SCANLAN® Easy-Tag™ Tracking System
Company
SCANLAN INTERNATIONAL INC
Model
1001-936
Catalog number
1001-936
Device description
Easy-Tag Pre-Printed, Repair, Small, Red 250/Spl
Published
2018-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159033045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159033045008461590330458461590330450846159033045

GMDN Terms#

Term, Definition table
TermDefinition
Device operating status label/tag, reusableA label or a tag intended to indicate the operating/calibration status (e.g., calibrated, repair required, out of service) and/or sterility record of the device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed to a specific standard. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
023055619
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159040524SCANLAN® Retractor8008-568008-562026-06-04
00846159040531SCANLAN® Retractor8008-598008-592026-06-04
00846159040548SCANLAN® Retractor8008-608008-602026-06-04
00846159040555SCANLAN® Retractor8888-058888-052026-06-04
00846159040562SCANLAN® Retractor8888-588888-582026-06-04
00846159040579SCANLAN® Retractor8989-188989-182026-06-04
00846159040586SCANLAN® RetractorQ195Q1952026-06-04
00846159040593SCANLAN® RetractorQ219Q2192026-06-04
00846159040609SCANLAN® RetractorQ222Q2222026-06-04
00846159040616SCANLAN® RetractorQ28124-38-2NQ28124-38-2N2026-06-04
00846159040623SCANLAN® RetractorQ28124-38-3NQ28124-38-3N2026-06-04
00846159040388SCANLAN® Retractor8008-1828008-1822026-06-03
00846159040395SCANLAN® Retractor8008-2008008-2002026-06-03
00846159040401SCANLAN® Retractor8008-2028008-2022026-06-03
00846159040418SCANLAN® Retractor8008-2048008-2042026-06-03
00846159040425SCANLAN® Retractor8008-24-18008-24-12026-06-03
00846159040432SCANLAN® Retractor8008-268008-262026-06-03
00846159040449SCANLAN® Retractor8008-26-18008-26-12026-06-03
00846159040456SCANLAN® Retractor8008-26-28008-26-22026-06-03
00846159040463SCANLAN® Retractor8008-288008-282026-06-03

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Primary DI, Brand, Company table
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07640152573989FISSOBaitella AGFWZ2025-10-13
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08056646508594Sheaths 120x7 cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508617Sheaths 240x7 cm cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508631Sheaths 120x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508655Sheaths 240x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508778OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508792OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508815Barrier sleeves for Osstell Beacon ISQ device - sterileOMNIA SRLFWZ2023-06-28
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