15X KLO Metal Self-Ligating -25.4

GUDID 06970469418644

PK OF 5

Zhejiang Headway Medical Equipment Co., Ltd

Orthodontic bracket, metal
Primary Device ID06970469418644
NIH Device Record Key7deaa25f-0dd1-4b18-ae8b-d410416ca944
Commercial Distribution StatusIn Commercial Distribution
Brand Name15X KLO Metal Self-Ligating -25.4
Version Model NumberBR15X-V
Company DUNS412892520
Company NameZhejiang Headway Medical Equipment Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970469418644 [Primary]

FDA Product Code

EJFBracket, Metal, Orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


[06970469418644]

Sound Waves


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-04
Device Publish Date2025-11-26

On-Brand Devices [15X KLO Metal Self-Ligating -25.4]

06970469419023PK OF 100
06970469418644PK OF 5

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