Black Belt II Tilting Arm Retractor Basic Set All Titanium

Basic Information

• Brand Name: Black Belt II Tilting Arm Retractor Basic Set All Titanium
• Primary DI: 10840199501783
• Version / Model: 7320-00MU
• Catalog Number: 7320-00MU
• 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: 2021-06-28
• Public Version: 2
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: 8c344d13-bf05-46bd-9d40-49c3e6a5bbd7

Device Description

Black Belt II Tilting Arm Retractor Basic Set All Titanium, Consists of the Following: 1x 7320-10TU - Black Belt II Ti Tilting Arm Retractor Frame Right, 1x 7320-20TU - Black Belt II Ti Tilting Arm Retractor Frame Left, 1x 7320-30TU - Black Belt II Ti Tilting Arm Retractor Frame Offset, 2x 7320-40M - Black Belt Retractor Blade Inserting Clamp SST, 2x 7322-34M - Black Belt Ti Blade Pronged 34mm, 2x 7322-40M - Black Belt Ti Blade Pronged 40mm, 2x 7322-45M - Black Belt Ti Blade Pronged 45mm, 2x 7322-50M - Black Belt Ti Blade Pronged 50mm, 2x 7322-55M - Black Belt Ti Blade Pronged 55mm, 2x 7322-60M - Black Belt Ti Blade Pronged 60mm, 2x 7322-70M - Black Belt Ti Blade Pronged 70mm, 2x 7324-34M - Black Belt Ti Blade Blunt 34mm, 2x 7324-40M - Black Belt Ti Blade Blunt 40mm, 2x 7324-45M - Black Belt Ti Blade Blunt 45mm, 2x 7324-50M - Black Belt Ti Blade Blunt 50mm, 2x 7324-55M - Black Belt Ti Blade Blunt 55mm, 2x 7324-60M - Black Belt Ti Blade Blunt 60mm, 2x 7324-70M - Black Belt Ti Blade Blunt 70mm, 2x 7326-40M - BB Two-Level Ti Blade Pronged 40mm, 2x 7326-47M - BB Two-Level Ti Blade Pronged 47mm, 2x 7326-55M - BB Two-Level Ti Blade Pronged 55mm, 2x 7328-40M - BB Two-Level Ti Blade Blunt 40mm, 2x 7328-47M - BB Two-Level Ti Blade Blunt 47mm, 2x 7328-55M - BB Two-Level Ti Blade Blunt 55mm, 1x 7320-90M - Black Belt Retractor Instrument Case

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	882.4800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45182	Self-retaining surgical retractor, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	00840199501786	GS1
Primary	10840199501783	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K935529	000

Storage Conditions

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