AccessGUDID - DEVICE: NA (04582275250374)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: NSPC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KONAN MEDICAL, INC.

Primary DI Number: 04582275250374
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 690768619 *Terms of Use

Device Description: No description.

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?
45729	Eye anterior segment analyser	A mains electricity (AC-powered) ophthalmic instrument intended to be used to measure and evaluate various properties of the anterior segment (i.e., cornea, iris, pupil, anterior chamber and lens). It is typically used for corneal topography, pachymetry, pupillometry and three-dimensional (3-D) analysis of the anterior eye segment using, e.g., revolving dual-channel Scheimpflug photography (viewing of the anterior segment in a sagittal plane) and Placido imaging (involves a disk with concentric white and black rings). It is typically computerized and provides output to a computer, with installed dedicated application software; the software may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQE	Microscope, specular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 44ba38ef-71eb-46c8-b66f-d2e145aaf190
Public Version Date: October 12, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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