CELLUGEL

GUDID 00380651838109

CELLUGEL 1.0ML 25G CELLUGEL® Ophthalmic Viscosurgical Device (OVD) is a sterile, nonpyrogenic, noninflammatory viscoelastic solution of highly purified non-proteinaceous 2% Hydroxypropyl Methylcellulose (HPMC) with an average molecular weight of 300,000 daltons dissolved in an isotonic, physiological buffer. Each mL of CELLUGEL® contains: 2% HPMC, 0.525% sodium chloride, 0.075% potassium chloride, 0.048% calcium chloride dihydrate, 0.03% magnesium chloride hexahydrate, 0.39% sodium acetate trihydrate, 0.17% sodium citrate dihydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid may be used as pH adjusters. The osmolarity of CELLUGEL® is 315 ± 35 mOsM/kg, the pH 7.2 ± 0.4, and the viscosity 30,000 ± 10,000 cps (at 0.2 sec-1, 25°C).

Alcon Laboratories, Inc.

Aqueous/vitreous humour replacement medium kit

• Primary Device ID: 00380651838109
• NIH Device Record Key: 3dba8d42-1a24-475d-8e98-08a842faaf1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELLUGEL
• Version Model Number: 8065183810
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)-862-5266
• Email: web.masterus@alcon.com

Device Dimensions

• Total Volume: 1 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380651838109 [Primary]
GS1	20380651838103 [Package]; Package: BOX [104 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990023

FDA Product Code

• LZP: Aid, Surgical, Viscoelastic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-15
• Device Publish Date: 2015-03-31

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