Eighteeth

GUDID 06941877803193

The HyperLight Hand-held Dental X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. This device must only be used in hospital environments, clinics or dental offices where appropriate safeguards are implemented, and not used in the oxygen-rich environment.

Changzhou Sifary Medical Technology Co., Ltd.

Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital
Primary Device ID06941877803193
NIH Device Record Key093965eb-de94-42a3-b3c6-339751982444
Commercial Distribution StatusIn Commercial Distribution
Brand NameEighteeth
Version Model NumberHyperLight
Company DUNS560366787
Company NameChangzhou Sifary Medical Technology 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
GS106941877803193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EHDUnit, X-Ray, Extraoral With Timer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-03
Device Publish Date2024-03-26

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06975132955471ibG3035D
06975132955457ibG3035D
06975132955433ibG3035D
06975132955419ibG3035D
06975132955396ibG3035D
06975132955372ibG3040D
06975132955358ibG3040D
06975132955334ibG3040D
06975132955310ibG3040D
06975132955297ibG3050D
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Trademark Results [Eighteeth]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EIGHTEETH
EIGHTEETH
79346677 not registered Live/Pending
Changzhou Sifary Medical Technology Co., Ltd.
2022-06-29
EIGHTEETH
EIGHTEETH
79251962 not registered Dead/Abandoned
Changzhou Sifary Medical Technology Co., Ltd.
2018-11-23
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