AccessGUDID - DEVICE: FRESNEL PRISM AND LENS (00850029104216)

GUDID

Device Identifier (DI) Information

Brand Name: FRESNEL PRISM AND LENS
Version or Model: 4000-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4000-15
Company Name: Fresnel Prism & Lens Company

Primary DI Number: 00850029104216
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789337987 *Terms of Use

Device Description: TRIAL RING - 15 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?
36068	Trial lens set	A set of ophthalmic trial lenses of various dioptric powers intended for vision testing to determine the required refraction. This device typically includes other related devices such as a trial frame into which the trial lenses can be rapidly exchanged during the examination.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HPC	Set, Lens, Trial, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad30faef-78ea-480c-8a9f-6ee623cad1af
Public Version Date: May 27, 2021
Public Version Number: 2
DI Record Publish Date: March 29, 2021