AccessGUDID - DEVICE: Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) (M687PR00018000)

GUDID

Device Identifier (DI) Information

Brand Name: Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz)
Version or Model: WA 2.2X
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PR00018-00
Company Name: VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.

Primary DI Number: M687PR00018000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532007614 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
58434	Intraocular telescope	An implantable optical device designed to improve visual acuity in patients with bilateral moderate to profound central vision impairment due to age related macular degeneration. It is a non-active micro-Galilean telescope consisting of a doublet lens confined in a glass cylinder intended to replace the natural lens of the eye. The device functions together with the cornea as a telephoto system to render an enlarged image on the retina to improve vision. Disposable devices associated with implantation may be included with the lens.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NCJ	Telescope, Implantable, Miniature

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P050034	012

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 Atmospheric Pressure: between 50.66 and 121.59 KiloPascal
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 43 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44e1f1cd-5de0-4469-b07f-48ae2d997290
Public Version Date: July 08, 2021
Public Version Number: 4
DI Record Publish Date: September 18, 2014