AccessGUDID - DEVICE: Irrigating Contact Lens (00853480006136)

GUDID

Device Identifier (DI) Information

Brand Name: Irrigating Contact Lens
Version or Model: Flat
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TR9840-11
Company Name: ESCALON MEDICAL CORP.

Primary DI Number: 00853480006136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 879144426 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58070	Vitrectomy contact lens, single-use	A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYG	Device, Irrigation, Ocular Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924999	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8baf9317-8a69-44a5-9a9e-b93601129528
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 14, 2016