CELLUGEL
Basic Information
- Brand Name
- CELLUGEL
- Primary DI
- 00380651838109
- Version / Model
- 8065183810
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-31
- Public Version
- 4
- Public Version Date
- 2019-04-15
- Public Version Status
- Update
- Public Device Record Key
- 3dba8d42-1a24-475d-8e98-08a842faaf1f
Device Description
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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | 886.4275 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36108 | Aqueous/vitreous humour replacement medium kit | A collection of sterile devices, including a fluid or semifluid substance, used in combination to replace the fluid of the eye. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380651838109 | GS1 | ||||
| Package | 20380651838103 | GS1 | BOX | 104 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)-862-5266
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Milliliter |