Xpand

GUDID 00813059012166

Xpand NT Iris Speculum, 6.7mm, Multi-Use

Diamatrix

Intraocular retractor, single-use

• Primary Device ID: 00813059012166
• NIH Device Record Key: f79eed72-4959-4816-9ac3-bc7a45c5d314
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpand
• Version Model Number: 146701
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00813059012166 [Primary]

FDA Product Code

• HOC: Clip, Iris Retractor

Sterilization

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

[00813059012166]

Moist Heat or Steam Sterilization

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