Long Cervical Micro-Bayonet Curette Set

Basic Information

• Brand Name: Long Cervical Micro-Bayonet Curette Set
• Primary DI: 10840199543752
• Version / Model: 7418-00L
• Catalog Number: 7418-00L
• 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: 703a0840-3187-4f7d-99de-a3a0cb50e198

Device Description

Aescalap Type Long Cervical Micro-Bayonet Curette Set Consists of the Following: 1 x 7418-10L, 1 x 7418-20L, 1 x 7418-30L, 1 x 7418-40L, 1 x 7418-80L, 1 x 7418-12L, 1 x 7418-22L, 1 x 7418-32L, 1 x 7418-42L, 1 x 7418-82L, 1 x 7418-14L, 1 x 7418-24L, 1 x 7418-34L, 1 x 7418-44L, 1 x 7418-84L, 1 x 7418-16L, 1 x 7418-26L, 1 x 7418-36L, 1 x 7418-46L, 1 x 7418-91L, 1 x 7418-92L, 1 x 7418-93 & 1 x 7418-95

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
FZS	Curette, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31335	Bone curette, reusable	A manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.	No	Active
32772	Ophthalmic curette, reusable	A hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a reusable device.	No	Active
62558	General-purpose curette	A hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	00840199543755	GS1
Primary	10840199543752	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3mm tip

Storage Conditions

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