FDA.reportPublic FDA data

SCANLAN® Instrumentation

Primary DI
00846159033656
Brand
SCANLAN® Instrumentation
Company
SCANLAN INTERNATIONAL INC
Model
Q39035-09
Catalog number
Q39035-09
Device description
Kerrison Style Wire Cutter
Published
2022-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXZCutter, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159033656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159033656008461590336568461590336560846159033656

GMDN Terms#

Term, Definition table
TermDefinition
Wire-extracting pliersA manual surgical instrument specially designed to grip the end of a wire, typically the self-boring type, for its extraction from the patient's body. It has a scissors-like design with strong curved handles and short pointed jaws that are heavily serrated to grip the end of the wire for extraction. It is made of high-grade stainless steel and some types can have a threaded screw that the surgeon tightens which increases the pressure (the grip) on the jaws. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159036404SCANLAN® Bulldog Clamp3795-553795-552026-06-09
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

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Primary DI, Brand, Company table
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08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09
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