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 ID00380651838109
NIH Device Record Key3dba8d42-1a24-475d-8e98-08a842faaf1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCELLUGEL
Version Model Number8065183810
Company DUNS008018525
Company NameAlcon Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)-862-5266
Emailweb.masterus@alcon.com

Device Dimensions

Total Volume1 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100380651838109 [Primary]
GS120380651838103 [Package]
Package: BOX [104 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZPAid, Surgical, Viscoelastic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-15
Device Publish Date2015-03-31

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Trademark Results [CELLUGEL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CELLUGEL
CELLUGEL
75089379 2039077 Live/Registered
NOVARTIS AG
1996-04-16
CELLUGEL
CELLUGEL
73760492 1540080 Dead/Cancelled
VISION BIOLOGY, INC.
1988-10-28

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