AccessGUDID - DEVICE: Applanation Tonometer (06973211070671)

GUDID

Device Identifier (DI) Information

Brand Name: Applanation Tonometer
Version or Model: SK-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD

Primary DI Number: 06973211070671
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545824560 *Terms of Use

Device Description: It is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid the diagnosis of glaucoma

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?
32721	Ophthalmic tonometer, manual	An ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKY	Tonometer, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191314	000

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: 5d25bd96-426b-4022-954b-ea27716bea9a
Public Version Date: July 10, 2020
Public Version Number: 1
DI Record Publish Date: July 02, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
26973211070491	2	06973211070671	In Commercial Distribution
26973211070507	4	06973211070671	In Commercial Distribution
26973211070514	6	06973211070671	In Commercial Distribution
26973211070521	8	06973211070671	In Commercial Distribution