Applanation Tonometer

GUDID 26973211070453

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

CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD

Ophthalmic tonometer, manual
Primary Device ID26973211070453
NIH Device Record Keybdf8d4af-944b-4f38-8fad-4396fed658b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameApplanation Tonometer
Version Model NumberSK-Q
Company DUNS545824560
Company NameCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973211070664 [Primary]
GS126973211070453 [Package]
Contains: 06973211070664
Package: [2 Units]
In Commercial Distribution
GS126973211070460 [Package]
Contains: 06973211070664
Package: [4 Units]
In Commercial Distribution
GS126973211070477 [Package]
Contains: 06973211070664
Package: [6 Units]
In Commercial Distribution
GS126973211070484 [Package]
Contains: 06973211070664
Package: [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKYTonometer, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-10
Device Publish Date2020-07-02

On-Brand Devices [Applanation Tonometer]

26973211070491It is a manual device intended for measurement of intraocular pressure by applanation (applying
26973211070453It is a manual device intended for measurement of intraocular pressure by applanation (applying
26973211070415It is a manual device intended for measurement of intraocular pressure by applanation (applying

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