DEVICE: CELLUGEL (00380651838109)

Device Identifier (DI) Information

CELLUGEL
8065183810
In Commercial Distribution

Alcon Laboratories, Inc.
00380651838109
GS1

1
008018525 *Terms of Use
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).
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
LZP Aid, Surgical, Viscoelastic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P990023 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Total Volume: 1 Milliliter
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Device Record Status

3dba8d42-1a24-475d-8e98-08a842faaf1f
July 06, 2018
3
March 31, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20380651838103 104 00380651838109 In Commercial Distribution BOX
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)-862-5266
web.masterus@alcon.com
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