AccessGUDID - DEVICE: i.Terminal 2 (04250668606694)

GUDID

Device Identifier (DI) Information

Brand Name: i.Terminal 2
Version or Model: 000000-1898-991
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000000-1898-991
Company Name: Carl Zeiss Vision GmbH

Primary DI Number: 04250668606694
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333928146 *Terms of Use

Device Description: N/A

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?
12805	Ophthalmodiastimeter	An ophthalmic instrument for determining the proper distance at which to place prescription lenses for the two eyes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMM	Distometer

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
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: less than 795 millibar
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: less than 795 millibar
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1a03a0e-16a0-45ad-a8ce-4e943b78248f
Public Version Date: October 05, 2021
Public Version Number: 2
DI Record Publish Date: January 01, 2021