Xpand

Basic Information

• Brand Name: Xpand
• Primary DI: 00813059013927
• Version / Model: 346722
• Company Name: Diamatrix
• Labeler DUNS: 809555139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-24
• Public Version: 1
• Public Version Date: 2019-11-01
• Public Version Status: New
• Public Device Record Key: ca96b49e-df34-414a-b457-0fb0d9f7fbb5

Device Description

Xpand X1 Ready-Loaded Iris Speculum, 6.7mm, Single-Use

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: 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
HOC	Clip, Iris Retractor	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46698	Intraocular retractor, single-use	A sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00813059013934	GS1	Box	4	In Commercial Distribution
Primary	00813059013927	GS1