FDA.reportPublic FDA data

SCANLAN® Retractor

Primary DI
00846159040265
Brand
SCANLAN® Retractor
Company
SCANLAN INTERNATIONAL INC
Model
109-HX1
Catalog number
109-HX1
Device description
CardioVasive™ Retractor Blade, Articulating Immobilizer, Custom
Published
2026-06-01
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159040265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159040265008461590402658461590402650846159040265

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. 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
00846159040272SCANLAN® Retractor109-I109-I2026-06-02
00846159040289SCANLAN® Retractor109-IC109-IC2026-06-02
00846159040296SCANLAN® Retractor109-K109-K2026-06-02
00846159040302SCANLAN® Retractor109-L109-L2026-06-02
00846159040319SCANLAN® Retractor109-M109-M2026-06-02
00846159040326SCANLAN® Retractor109-N109-N2026-06-02
00846159040333SCANLAN® Retractor109-Q109-Q2026-06-02
00846159040340SCANLAN® Retractor109-R109-R2026-06-02
00846159040357SCANLAN® Retractor8008-1728008-1722026-06-02
00846159040364SCANLAN® Retractor8008-1748008-1742026-06-02
00846159040371SCANLAN® Retractor8008-1808008-1802026-06-02
00846159040197SCANLAN® Retractor109-C109-C2026-06-01
00846159040203SCANLAN® Retractor109-D109-D2026-06-01
00846159040210SCANLAN® Retractor109-E109-E2026-06-01
00846159040227SCANLAN® Retractor109-F109-F2026-06-01
00846159040234SCANLAN® Retractor109-G109-G2026-06-01
00846159040241SCANLAN® Retractor109-H109-H2026-06-01
00846159040258SCANLAN® Retractor109-HC109-HC2026-06-01
00846159040135SCANLAN® Retractor109-A109-A2026-05-29
00846159040142SCANLAN® Retractor109-A1109-A12026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159040272SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040289SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040296SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040302SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040319SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040326SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040333SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040340SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040357SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040364SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040371SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
B7687425470Buxton BioMedicalBuxton Biomedical IncGAD2026-06-02
B7687425570Buxton BioMedicalBuxton Biomedical IncGAD2026-06-02
00810055254897Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055254903Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258871Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258888Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258895Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258901Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258918Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258925Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258932Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258956Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258963Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258970Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258987Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258994Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055259007Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055259014Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055259021Surgical DesignSurgical Design, Inc.GAD2026-06-01