20ga DEX™ Hassan Forceps

Basic Information

• Brand Name: 20ga DEX™ Hassan Forceps
• Primary DI: 10817489029944
• Version / Model: DVFO4035-20
• Company Name: KATALYST SURGICAL LLC
• Labeler DUNS: 007883297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-05-31
• Public Version: 2
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: 8a562f06-a4b1-4c88-b5dd-113e716a7711

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: No
• PM Exempt: Yes
• 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
HNR	Forceps, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62478	Ophthalmic soft-tissue manipulation forceps, probe-like, single-use	A sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817489029944	GS1
Unit of Use	00817489029947	GS1