DEVICE: PERFLUORON (00380659001635)

Device Identifier (DI) Information

PERFLUORON
0090010015
In Commercial Distribution
8065900163
Alcon Laboratories, Inc.
00380659001635
GS1

1
008018525 *Terms of Use
PFNO KIT 5ML<USA Kit Contents: One 5 mL vial of sterile PERFLUORON Liquid One 10 mL syringe One 20 gauge beveled needle One 0.2 micron filter unit One 23 gauge blunt cannula One PERFLUORON Liquid package insert
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LWL Fluid, Intraocular
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P950018 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Total Volume: 5 Milliliter
CLOSE

Device Record Status

a4e4c8ad-c906-4a00-815a-3369e876cdcf
July 06, 2018
3
March 06, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10380659001632 3 00380659001635 In Commercial Distribution BOX
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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