FDA.reportPublic FDA data

Scanlan® SURG-I-BAND® color coding

Primary DI
00846159015621
Brand
Scanlan® SURG-I-BAND® color coding
Company
SCANLAN INTERNATIONAL INC
Model
1001-1008
Catalog number
1001-1008
Device description
"Scanlan® SURG-I-BAND® color coding - Designs on Spool, Number Eight, Red, 1 spool, 1/4"" width"
Published
2017-07-11
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
00846159015621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159015621008461590156218461590156210846159015621

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument track identification tapeA non-sterile, colour-coded, band coated on one side with a pressure-sensitive adhesive intended to attach to a surgical instrument; it is typically wrapped around the handle or shaft to indicate instrument ownership (e.g., by doctor, hospital floor, department or ward) and identifies the instrument prior to and during a surgical procedure. This marking will facilitate that the correct instruments are returned to the correct owner particularly after being sterilized in the hospital sterilization department or other facility. It is typically made of plastic material and is available in a sheet with different size strips of tape or in continuous roll (a spool). This is a single-use 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159039269SCANLAN® ForcepsQ26049-4Q26049-42026-05-26
00846159039276SCANLAN® ForcepsQ26065-4NQ26065-4N2026-05-26
00846159039283SCANLAN® ForcepsQ27036-34Q27036-342026-05-26
00846159039290SCANLAN® ForcepsQ27047-34NQ27047-34N2026-05-26
00846159039306SCANLAN® ClampQ27052-2Q27052-22026-05-26
00846159039313SCANLAN® ClampQ27058-9Q27058-92026-05-26
00846159039320SCANLAN® ForcepsQ27064-4Q27064-42026-05-26
00846159039337SCANLAN® ForcepsQ27080-34NQ27080-34N2026-05-26
00846159039344SCANLAN® ForcepsQ27081-4NQ27081-4N2026-05-26
00846159039351SCANLAN® ClampQ27107-2Q27107-22026-05-26
00846159039368SCANLAN® ClampQ27108-2Q27108-22026-05-26
00846159039375SCANLAN® ClampQ27109-2Q27109-22026-05-26
00846159039382SCANLAN® ClampQ27110-2Q27110-22026-05-26
00846159039399SCANLAN® ForcepsQ27112-34Q27112-342026-05-26
00846159039405SCANLAN® ForcepsQ28011-4Q28011-42026-05-26
00846159039412SCANLAN® ClampQ28016-9Q28016-92026-05-26
00846159039429SCANLAN® ClampQ28018Q280182026-05-26
00846159039436SCANLAN® ClampQ28027-32Q28027-322026-05-26
00846159039443SCANLAN® ForcepsQ28033-4Q28033-42026-05-26
00846159039450SCANLAN® ClampQ28046-2Q28046-22026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00696588008370MorphBoard®Innovative Medical Products, IncFWZ2026-05-19
00696588008325De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-07
00696588008264De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008271De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008288De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008295De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008301De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
00696588008318De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
07640152574245FISSOBaitella AGFWZ2026-04-01
07640152574252FISSOBaitella AGFWZ2026-04-01
07640152574269FISSOBaitella AGFWZ2026-04-01
07640152574276FISSOBaitella AGFWZ2026-04-01
07640152574283FISSOBaitella AGFWZ2026-04-01
10653405986379CONMEDConmed CorporationFWZ2026-01-17
00696588008233De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-11-21
00810014600598SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
00810014600666SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
00810014600833SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
00810014602714SchureMedSCHUERCH CORPORATIONFWZ2025-10-29
07640152573989FISSOBaitella AGFWZ2025-10-13
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
00733657288131ATEC KIT 4 STRAPSALIMED, INC.FWZ2024-08-02
08056646508570Transparent drape 40x50 cm with adhesive tape for physiodispensers or for controOMNIA SRLFWZ2023-06-28
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