AccessGUDID - DEVICE: SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT® (00852475007042)

GUDID

Device Identifier (DI) Information

Brand Name: SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®
Version or Model: 40240
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40240
Company Name: OCULUS SURGICAL INC

Primary DI Number: 00852475007042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015409582 *Terms of Use

Device Description: 1 Each SUPER VIEW® Sterile Disposable HD Plus Lens Set for use with ZEISS RESIGHT®

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):	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?
47946	Ophthalmic diagnostic condensing lens	An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051630	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 -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14536717-e28e-449c-9801-aa3372697959
Public Version Date: June 17, 2022
Public Version Number: 3
DI Record Publish Date: November 24, 2020