Specula Retractor Set

Basic Information

• Brand Name: Specula Retractor Set
• Primary DI: 10840199543400
• Version / Model: 7271-00
• Catalog Number: 7271-00
• Company Name: KOROS U.S.A., INC.
• Labeler DUNS: 007928633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-23
• Public Version: 1
• Public Version Date: 2022-07-01
• Public Version Status: New
• Public Device Record Key: 48508253-a889-4e29-b395-f7d001bdae52

Device Description

Lumbar Micro Disc Specula Retractor Set Consists of the Following: 1 x 7270-40 Lumbar Micro Discectomy Specula Retractor 40mm, 1 x 7270-45 Lumbar Micro Discectomy Specula Retractor 45mm, 1 x 7270-50 Lumbar Micro Discectomy Specula Retractor 50mm, 1 x 7270-55 Lumbar Micro Discectomy Specula Retractor 55mm, 1 x 7270-60 Lumbar Micro Discectomy Specula Retractor 60mm, 1 x 7272-20 Micro Discectomy Specula Cross Retractor Frame Only, 1 x 7272-40 Micro Discectomy Blade 40mm Deep, 1 x 7272-45 Micro Discectomy Blade 45mm Deep, 1 x 7272-50 Micro Discectomy Blade 50mm Deep, 1 x 7272-55 Micro Discectomy Blade 55mm Deep, 1 x 7272-60 Micro Discectomy Blade 60mm Deep, 1 x 7272-65 Micro Discectomy Blade 65mm Deep & 1 x 7268-80 Blade Ejector

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
46774	Surgical retractor/retraction system blade, reusable	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	00840199543403	GS1
Primary	10840199543400	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			9x12mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dry place at room temperature