1.3MM CCK W/Marks

Basic Information

• Brand Name: 1.3MM CCK W/Marks
• Primary DI: 00848782004850
• Version / Model: 82-1361G
• Catalog Number: 82-1361G
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• Labeler DUNS: 812762226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-30
• Public Version: 2
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: d6a20dba-277c-495b-acdc-a72f86449d70

Device Description

1.3MM CCK W/Marks

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNN	Knife, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46741	Ophthalmic knife, single-use	A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10848782004857	GS1	Box	5	In Commercial Distribution
Primary	00848782004850	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K822112	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.3MM