AccessGUDID - DEVICE: Ocular Surface Analyzer (06973211070787)

GUDID

Device Identifier (DI) Information

Brand Name: Ocular Surface Analyzer
Version or Model: DA-3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD

Primary DI Number: 06973211070787
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545824560 *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?
62593	Meibomian gland camera/ophthalmic interferometer	A mains electricity (AC-powered) multi-purpose optical device intended for: 1) infrared (IR) image capture of the meibomian glands for evaluation of structural abnormalities of the meibomian glands; 2) measurement of the tear film lipid layer using white light image/video capture interferometry; and 3) image capture of the external ocular anatomy. It includes patient head/chin supports, an IR source(s), appropriate cameras, controls and software intended to allow analysis of the images/video and interferometry; it may include an eyelid everter to assist imaging of the meibomian glands.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJZ	Camera, Ophthalmic, General-Use

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: c4ff8832-6dfa-4ebe-af69-97dd0940cfb8
Public Version Date: June 23, 2021
Public Version Number: 1
DI Record Publish Date: June 15, 2021