Oph.Spoon

Basic Information

• Brand Name: Oph.Spoon
• Primary DI: 00841668119976
• Version / Model: 08-13102
• Catalog Number: 08-13102
• Company Name: KATENA PRODUCTS, INC.
• Labeler DUNS: 085668598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-16
• Public Version: 1
• Public Version Date: 2022-11-24
• Public Version Status: New
• Public Device Record Key: 09e8c6a9-d2b5-4e3d-b3ce-a2d58b461a76

Device Description

Bunge Evisceration Spoon, Large 11mm cup

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNB	Spoon, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35153	Lens spoon	A hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye. It is typically made of high-grade stainless steel and has a spoon-shaped distal working end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841668119976	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	11	Millimeter