CRANDALL CAPSULORRHEXIS INCISION GAUGES

Basic Information

• Brand Name: CRANDALL CAPSULORRHEXIS INCISION GAUGES
• Primary DI: 00841668127872
• Version / Model: AE-1582T
• Catalog Number: AE-1582T
• Company Name: KATENA PRODUCTS, INC.
• Labeler DUNS: 085668598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: f0ab776f-2c18-4a49-ae78-eae3c5aed5d7

Device Description

CRANDALL CAPSULORRHEXIS INCISION GAUGES

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
HOE	Caliper, ophthalmic	Ophthalmic	886.4350	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	00841668127872	GS1

Customer Contacts

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