AccessGUDID - DEVICE: FRESNEL PRISM AND LENS (00850029104773)

GUDID

Device Identifier (DI) Information

Brand Name: FRESNEL PRISM AND LENS
Version or Model: 3120-F
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3120-F
Company Name: Fresnel Prism & Lens Company

Primary DI Number: 00850029104773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789337987 *Terms of Use

Device Description: FRESNEL LENS, D-SEGMENT, 12.0 DIOPTER

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):	Yes
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?
32693	Fresnel lens	A very thin and flexible ophthalmic lens intended to be applied to the back of spectacle lenses to focus light to a focal point to help manage various vision conditions including aphakia (absence of the lens of the eye), myopia, hyperopia, and presbyopia. It is typically made of glass or plastic and its surface is a concentric series of increasingly refractive zones.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKT	Prism, Fresnel, Ophthalmic

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
Special Storage Condition, Specify: STORE AT ROOM TEMPERATURE, AVOID EXESSIVE HEAT AND HUMIDITY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40b2663b-3efe-4c47-bac8-0c77bb415e6c
Public Version Date: February 13, 2023
Public Version Number: 1
DI Record Publish Date: February 05, 2023