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 |
| 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 |
Devices Manufactured by Alcon Laboratories, Inc.
| 10380657530660 - UNIPURE & UNIFEYE | 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated |
| 10380657530677 - UNIPURE & UNIFEYE | 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated |
| 10380657530684 - UNIPURE & UNIPEXY | 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated |
| 10380657530691 - UNIPURE & UNIPEXY | 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated r |
| 17612717072098 - FINESSE ModifEYE | 2024-10-04 25G ModifEYE Soft Tip Backflush - Long |
| 17612717072104 - FINESSE ModifEYE | 2024-10-04 27+ ModifEYE Soft Tip Backflush - Long |
| 17612717072067 - FINESSE ModifEYE | 2024-10-03 25G ModifEYE Soft Tip Backflush |
| 17612717072074 - FINESSE ModifEYE | 2024-10-03 27+ ModifEYE Soft Tip Backflush |
Trademark Results [CELLUGEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLUGEL 75089379 2039077 Live/Registered |
NOVARTIS AG 1996-04-16 |
 CELLUGEL 73760492 1540080 Dead/Cancelled |
VISION BIOLOGY, INC. 1988-10-28 |
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