FDA.reportPublic FDA data

SCANLAN® Retractor

Primary DI
00846159021011
Brand
SCANLAN® Retractor
Company
SCANLAN INTERNATIONAL INC
Model
8008-01
Catalog number
8008-01
Device description
Ionescu Double Ended Leaflet Valve Retractor
Published
2016-07-22
Public version status
Update
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
00846159021011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159021011008461590210118461590210110846159021011

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
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

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Primary DI, Brand, Company table
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