Dental Cone-beam Computed Tomography

GUDID 06975023419013

Yian Medical Technology (Haining) Co., Ltd.

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Primary Device ID06975023419013
NIH Device Record Key4fc6f84b-edf0-4ad6-8266-4eced54815fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameDental Cone-beam Computed Tomography
Version Model NumberiDT901X1
Company DUNS713686549
Company NameYian Medical Technology (Haining) 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 Datetrue
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
GS106975023419013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-22
Device Publish Date2024-01-12

Devices Manufactured by Yian Medical Technology (Haining) Co., Ltd.

06975023419013 - Dental Cone-beam Computed Tomography2024-01-22
06975023419013 - Dental Cone-beam Computed Tomography2024-01-22
06975023416012 - Yian Medical Technology (Haining) Co., Ltd.2022-07-05 The Heart3R-110 is Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population f
06975023416029 - Yian Medical Technology (Haining) Co., Ltd.2022-07-05 The Heart5R-110 is Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population f

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