Oph. Caliper

Basic Information

• Brand Name: Oph. Caliper
• Primary DI: 00841668119860
• Version / Model: 08-12110
• Catalog Number: 08-12110
• 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: 3e1a834f-10cd-4241-be57-660e2d84d993

Device Description

Rhein Incision Gauges, 100µm, 2.5-4.0mm

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
FTY	TAPE, MEASURING, RULERS AND CALIPERS	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63538	Ophthalmic surgical incision gauge	A manual surgical instrument intended to be used during an ophthalmic surgical procedure to measure the length of an incision made on the surface of the eye (cornea or sclera). It typically consists of a hand-held metal tool with graduations. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841668119860	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	2.5	Millimeter
Length	4	Millimeter