AccessGUDID - DEVICE: Lee-Mainster SLO 60-2 Retina Lens (00630238088206)

GUDID

Device Identifier (DI) Information

Brand Name: Lee-Mainster SLO 60-2 Retina Lens
Version or Model: OSLO60-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OCULAR INSTRUMENTS, INC.

Primary DI Number: 00630238088206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 046212387 *Terms of Use

Device Description: No description.

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:	No
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?
47947	Hruby fundus lens	A 55 dioptre non-contact diagnostic ophthalmic lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HJL	Lens, Condensing, Diagnostic

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bef00475-a1cd-4240-8cb2-5b05192f9e69
Public Version Date: March 15, 2021
Public Version Number: 2
DI Record Publish Date: June 10, 2019