Pantheris

GUDID 06975417183889

Zylox-Tonbridge Medical Technology Co., Ltd.

Blood donor set, triple-pack
Primary Device ID06975417183889
NIH Device Record Key6e1b97fc-0e16-403e-b1b4-7e7cc9313e8b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePantheris
Version Model NumberA110-LV
Company DUNS542983873
Company NameZylox-Tonbridge 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975417183889 [Primary]

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-30
Device Publish Date2026-03-21

On-Brand Devices [Pantheris]

06975417183889A110-LV
06975417183872A140-SV
06975417183865A400X
06975417183858A400

Trademark Results [Pantheris]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PANTHERIS
PANTHERIS
85863579 4837148 Live/Registered
Avinger, Inc.
2013-02-28

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