Xpand

GUDID 00813059013934

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

Diamatrix

Intraocular retractor, single-use

• Primary Device ID: 00813059013934
• NIH Device Record Key: ca96b49e-df34-414a-b457-0fb0d9f7fbb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpand
• Version Model Number: 346722
• Company DUNS: 809555139
• Company Name: Diamatrix
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813059013927 [Primary]
GS1	00813059013934 [Package]; Contains: 00813059013927; Package: Box [4 Units]; In Commercial Distribution

FDA Product Code

• HOC: Clip, Iris Retractor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-01
• Device Publish Date: 2019-10-24

On-Brand Devices [Xpand]

• 00813059013934: Xpand X1 Ready-Loaded Iris Speculum, 6.7mm, Single-Use
• 00813059012166: Xpand NT Iris Speculum, 6.7mm, Multi-Use