EACU, EAKU, JOCU, ZAGU

GUDID B338NKJ16301

Maanshan Bond Medical Instruments Co., Ltd.

Acupuncture needle, single-use
Primary Device IDB338NKJ16301
NIH Device Record Key693cc3ba-5c38-458f-8289-57d0d926d601
Commercial Distribution StatusIn Commercial Distribution
Brand NameEACU, EAKU, JOCU, ZAGU
Version Model NumberNKJ1630
Company DUNS421257620
Company NameMaanshan Bond Medical Instruments Co., Ltd.
Device Count100
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 Datefalse
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
HIBCCB338NKJ16300 [Unit of Use]
HIBCCB338NKJ16301 [Primary]
HIBCCB338NKJ16302 [Package]
Package: bigger box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQXNeedle, Acupuncture, Single Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-18
Device Publish Date2016-09-29

On-Brand Devices [EACU, EAKU, JOCU, ZAGU]

B338PTN22162PTN2216
B338NKJ30752NKJ3075
B338NKJ25752NKJ2575
B338NKJ25152NKJ2515
B338NKJ16301NKJ1630
NKJ14302NKJ1430
B338IDN12052IDN1205
B338HB18081HB1808
B338DPB20072DPB2007
B338DPB18072DPB1807
B338DPB16071DPB1607
B338CB35251CB3525
B33810K2230110K2230
B33810K2215110K2215
B33810K2030110K2030
B33810K2015110K2015
B33810K1840210K1840
B33810K1830110K1830
B33810K1815110K1815
B33810K1630110K1630
B3385NKJ254025NKJ2540
B3385NKJ253025NKJ2530
B3385NKJ224025NKJ2240
B3385NKJ223025NKJ2230
B3385NKJ203025NKJ2030
B3385NKJ183005NKJ1830
B3385NKJ164005NKJ1640
B3385NKJ163005NKJ1630

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