FDA.report

SURJEX

Primary DI
G383WM8769921
Brand
SURJEX
Company
SURJEX
Model
WM8769921
Catalog number
WM8769921
Device description
Thorlakson Retractor, 125/175x35mm, 10"
Published
2026-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GADRetractor

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G383WM8769921PrimaryHIBCC0

GMDN Terms

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
Ethylene Oxide

Regulatory Flags

DUNS number
645518882
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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G3831053WM0415S365SURJEXWM0415S3WM0415S32024-06-27
G3831053WM0418S36L6SURJEXWM0418S3WM0418S32024-06-27
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G3831053WM1415S36J5SURJEXWM1415S3WM1415S32024-06-27

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