AccessGUDID - DEVICE: Lens Exchange Sytem (M687PR104013)

GUDID

Device Identifier (DI) Information

Brand Name: Lens Exchange Sytem
Version or Model: G25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PR00104-01
Company Name: VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.

Primary DI Number: M687PR104013
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 532007614 *Terms of Use

Device Description: Lens Exchange System LES G25 three unit package

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
62634	Intraocular lens implantation cord	A sterile device intended to be attached to, and enable temporary extension of, the haptic loops of an intraocular lens (IOL) to facilitate implantation of the IOL in the posterior chamber of the eye. It typically includes two lengths of cord with connectors and a mounting tray. It is often used during IOL replacement as an alternative to IOL injection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYB	Lens, Guide, Intraocular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: less than 43 Degrees Celsius
Special Storage Condition, Specify: Do not store the device in direct sunlight
Storage Environment Humidity: more than 20 Percent (%) Relative Humidity
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity
Storage Environment Temperature: more than 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1608c2e7-7bc0-4d60-bd37-549e301ef149
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 01, 2017