Irrigating Contact Lens TR9841-11

GUDID 00853480006143

For use during silicone oil procedures, irrigating contact lens enables visualization of surgical field while ensuring proper irrigation of cornea and orbit. Single use requiring no clean up.

ESCALON MEDICAL CORP.

Vitrectomy contact lens, single-use
Primary Device ID00853480006143
NIH Device Record Key9401d81a-8eb4-45bc-8d74-53a726eeed68
Commercial Distribution StatusIn Commercial Distribution
Brand NameIrrigating Contact Lens
Version Model NumberMinus
Catalog NumberTR9841-11
Company DUNS879144426
Company NameESCALON MEDICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-486-4848
Emailinfo@escalonmed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100853480006143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KYGDevice, Irrigation, Ocular Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-01-14

On-Brand Devices [Irrigating Contact Lens]

00853480006143For use during silicone oil procedures, irrigating contact lens enables visualization of surgica
00853480006136For use during silicone oil procedures, irrigating contact lens enables visualization of surgica

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