FDA.reportPublic FDA data

Swift Vascular Retractor Extended Set

Primary DI
10840199544759
Brand
Swift Vascular Retractor Extended Set
Company
KOROS U.S.A., INC.
Model
9880-15R
Catalog number
9880-15R
Device description
Swift Vascular Retractor Extended Radiolucent Set Consists of the Following:1 x 9881-10, 1 x 9881-12, 1 x 9881-20, 1 x 9881-22, 1 x 9551-50, 6 x 9881-70, 1 x 9881-90, 1 x 9881-92, 2 x 9882-14R, 1 x 9882-18R, 1 x 9882-30R, 1 x 9882-32R, 1 x 9882-44R, 1 x 9882-46R, 1 x 9882-62R, 1 x 9882-72R, 1 x 9882-74R, 1 x 9883-12R, 1 x 9881-28R, 1 x 9883-42R & 1 x 9881-44R
Published
2022-10-31
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
00840199544752Direct MarkingGS10
10840199544759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199544752008401995447528401995447520840199544752
1084019954475910840199544759

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags#

DUNS number
007928633
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10840199516008Fiberoptic Light Port7332-627332-622024-12-31
10840199516015Fiberoptic Light Port7332-647332-642024-12-31
10840199531056Impactor7585-027585-022022-03-01
10840199531186Impactor7585-447585-442022-03-01
10840199528834Comfort Plus Chisel7540-067540-062025-01-31
00840199528837Comfort Plus Chisel7540-067540-062025-01-31
10840199500007Dilator Tube Set, Single Use, Sterile 7332-99D7332-99D2022-01-31
10840199507723Separator7230-107230-102024-12-31
10840199507730Separator7230-157230-152024-12-31
10840199507747Elevator7230-187230-182024-12-31
10840199507754Elevator7230-207230-202024-12-31
10840199507761Elevator7230-257230-252024-12-31
10840199507778Elevator7230-307230-302024-12-31
10840199507785Elevator7230-357230-352024-12-31
10840199507792Elevator7230-407230-402024-12-31
10840199507808Elevator7230-427230-422024-12-31
10840199507815Elevator7230-437230-432024-12-31
10840199507877Elevator7230-607230-602024-12-31
10840199507907Hook7232-057232-052024-12-31

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Primary DI, Brand, Company table
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B382SD9079001010Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD97247105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-17