AccessGUDID - DEVICE: BK S2, without convex cylinders, coated, wooden case with handle (04049584001641)

GUDID

Device Identifier (DI) Information

Brand Name: BK S2, without convex cylinders, coated, wooden case with handle
Version or Model: 334911
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Primary DI Number: 04049584001641
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317138956 *Terms of Use

Device Description: BK S2, without convex cylinders, coated, wooden case with handle

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?
32791	Trial lens frame	A device used in ophthalmic work for placing, holding, and exchanging trial lenses in front of the eyes of the patient during a sight-testing procedure.	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
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d95a4fb-6813-4c6c-805e-b95abf4d5586
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022