Swift General Retractor Basic Set

Basic Information

• Brand Name: Swift General Retractor Basic Set
• Primary DI: 10840199544698
• Version / Model: 9880-00R
• Catalog Number: 9880-00R
• 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: 2022-10-31
• Public Version: 1
• Public Version Date: 2022-11-08
• Public Version Status: New
• Public Device Record Key: e88c9c86-5cfe-4c3f-a14b-91dc336babc1

Device Description

Swift General Retractor Basic Radiolucent Set Consists of the Following: 1 x 9881-10, 1 x 9881-12, 1 x 9881-20, 1 x 9881-22, 4 x 9881-70, 2 x 9882-14R, 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 9883-36R, 1 x 9883-38R, 1 x 9881-90 & 1 x 9881-92

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
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	00840199544691	GS1
Primary	10840199544698	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