FDA.reportPublic FDA data

SCANLAN® Retractors

Primary DI
00846159029727
Brand
SCANLAN® Retractors
Company
SCANLAN INTERNATIONAL INC
Model
Q2259-8
Catalog number
Q2259-8
Device description
"Pediatric Retractor, 6 mm, 5 1/2"" / 14 mm (Desmarres/Bailey Style)"
Published
2020-02-21
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159029727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159029727008461590297278461590297270846159029727

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159039672SCANLAN® Instrument3784-43N3784-43N2026-05-27
00846159039689SCANLAN® Instrument3784-44N3784-44N2026-05-27
00846159039696SCANLAN® Scissors7007-140N7007-140N2026-05-27
00846159039702SCANLAN® Scissors7007-216-1SCN7007-216-1SCN2026-05-27
00846159039719SCANLAN® Scissors7007-216-2SCN7007-216-2SCN2026-05-27
00846159039726SCANLAN® Scissors7007-401N7007-401N2026-05-27
00846159039733SCANLAN® Scissors7007-402N7007-402N2026-05-27
00846159039740SCANLAN® Scissors7007-403N7007-403N2026-05-27
00846159039757SCANLAN® Scissors7007-508N7007-508N2026-05-27
00846159039764SCANLAN® Scissors7007-509N7007-509N2026-05-27
00846159039771SCANLAN® Scissors7007-510N7007-510N2026-05-27
00846159039788SCANLAN® Instrument7506-557506-552026-05-27
00846159039795SCANLAN® Instrument8008-7008008-7002026-05-27
00846159039801SCANLAN® Instrument8008-908008-902026-05-27
00846159039818SCANLAN® ScissorsQ2108-7Q2108-72026-05-27
00846159039825SCANLAN® ScissorsQ2111-9Q2111-92026-05-27
00846159039832SCANLAN® ScissorsQ2129-7Q2129-72026-05-27
00846159039849SCANLAN® ScissorsQ2130-7Q2130-72026-05-27
00846159039856SCANLAN® ScissorsQ2325-9Q2325-92026-05-27
00846159039863SCANLAN® ForcepsQ2362-8Q2362-82026-05-27

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Primary DI, Brand, Company table
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07640375234711PERLA ® TL MISSpineArt SAGAD2025-11-10
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08800071700357Tiger ViewKims Med Co.,Ltd.GAD2025-02-10
08800071700371Tiger View Kims Med Co.,Ltd.GAD2025-02-10
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