N/A

GUDID 00810090013299

One package of 10 cellulose eye sponges

Eagle Labs

Ophthalmic sponge Ophthalmic sponge
Primary Device ID00810090013299
NIH Device Record Key650e6da7-5ba6-48f9-8c0c-1981c9e7431f
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number500-01
Company DUNS555862549
Company NameEagle Labs
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone909-481-0011
Emaileaglelabs@eaglelabs.com
Phone909-481-0011
Emaileaglelabs@eaglelabs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810090013299 [Primary]
GS110810090013296 [Package]
Package: carton [10 Units]
In Commercial Distribution

FDA Product Code

HOZSponge, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00810090013299]

Radiation Sterilization


[00810090013299]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-14

On-Brand Devices [N/A]

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10810090013968LASIK shield, 8mm diameter, 6mm edge
10810090013920LASIK sponge, 11mm opening
10810090013913LASIK Drainage Ring, Superior Hinge, 9.5mm opening
00810090013909Eye Pledget, Lint free PVS eye sponges, 2mm x 6mm - 10 in one package
10810090013517PVA Pre-expanded Eye Spears, 2 ea
10810090013494Non-woven Half Body drape with adhesive incise and fluid collection pouch
10810090013395LASIK Shield, 9mm diameter, 7mm edge
10810090013388LASIK Drainage Ring (Chayet), 12mm opening
10810090013302PVA Eye Spears - 5 ea
00810090013299One package of 10 cellulose eye sponges
10810090012602Refractive Drape, 16" x 10.7" (41cm x 27cm), with split aperture
10810090011612Medium plastic drape, 50" x 32" (127cm x 81cm), with adhesive aperture
10810090011476Medium plastic drape, 48" x 51" (122cm x 130cm), with adhesive incise and fluid collection
10810090011445Medium plastic drape, 48" x 50" (122cm x 127cm), with adhesive incise
10810090011438Small plastic drape, 16" x 16" (41cm x 41cm), with adhesive incise
10810090011292Small plastic drape, 16"x16" (41cm x 41cm), with adhesive aperture

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