FDA.reportPublic FDA data

Scanlan® SURG-I-LOOP® PLUS with semi-sharp needle

Primary DI
00846159027822
Brand
Scanlan® SURG-I-LOOP® PLUS with semi-sharp needle
Company
SCANLAN INTERNATIONAL INC
Model
1001-82PB
Catalog number
1001-82PB
Device description
Scanlan® SURG-I-LOOP® PLUS with semi-sharp needle - Light Orange, 37cm long, needle 1mm diam, Bulk Non-Sterile (20/pkg)
Published
2018-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAESnare, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAESnare, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159027822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159027822008461590278228461590278220846159027822

GMDN Terms#

Term, Definition table
TermDefinition
Surgical vessel loopA nonimplantable cord intended to be used during a surgical procedure to assist a surgeon to identify, retract and occlude blood vessels, tendons and nerves. It is constructed of synthetic polymer and is typically coloured to facilitate visualization. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation 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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159039931SCANLAN® ScissorsQ2423-7Q2423-72026-05-28
00846159039948SCANLAN® ScissorsQ2428-7Q2428-72026-05-28
00846159039955SCANLAN® ScissorsQ2429-7Q2429-72026-05-28
00846159039962SCANLAN® ScissorsQ2430-7Q2430-72026-05-28
00846159039979SCANLAN® ScissorsQ247-7Q247-72026-05-28
00846159039986SCANLAN® ScissorsQ25010-7Q25010-72026-05-28
00846159039993SCANLAN® ScissorsQ26044-7Q26044-72026-05-28
00846159040005SCANLAN® ScissorsQ27010-7Q27010-72026-05-28
00846159040012SCANLAN® ScissorsQ27065-7Q27065-72026-05-28
00846159040029SCANLAN® ScissorsQ27079-7NQ27079-7N2026-05-28
00846159040036SCANLAN® ScissorsQ27082-7NQ27082-7N2026-05-28
00846159040043SCANLAN® ScissorsQ27119-7Q27119-72026-05-28
00846159040050SCANLAN® ScissorsQ28032-7Q28032-72026-05-28
00846159040067SCANLAN® ScissorsQ28080-7Q28080-72026-05-28
00846159040074SCANLAN® ScissorsQ28097-7Q28097-72026-05-28
00846159040081SCANLAN® ScissorsQ28119-9Q28119-92026-05-28
00846159040098SCANLAN® ScissorsQ29092-9Q29092-92026-05-28
00846159040104SCANLAN® ScissorsQ32034-7NQ32034-7N2026-05-28
00846159040111SCANLAN® ScissorsQ32035-7NQ32035-7N2026-05-28
00846159040128SCANLAN® ScissorsQ33032-7NQ33032-7N2026-05-28

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