SURJEX

Basic Information

• Brand Name: SURJEX
• Primary DI: G383CLOWARDBLADERETRAF6
• Version / Model: WM9873320 to WM9873333
• Catalog Number: WM9873320 to WM9873333
• Company Name: SURJEX
• Labeler DUNS: 645518882
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-30
• Public Version: 1
• Public Version Date: 2024-05-08
• Public Version Status: New
• Public Device Record Key: a9a8932f-d64e-4fce-9c1a-632bd06d0e43

Device Description

CLOWARD BLADE RETRACTOR 7.5" BLADE 13MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 18MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 20MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 23MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 30MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 33MM WITH LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 13MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 18MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 20MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 23MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 30MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 33MM NO LIP

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45918	Hand-held surgical retractor, reusable	A hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G383CLOWARDBLADERETRAF6	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]