FDA.reportPublic FDA data

EACU, EAKU, ZAGU, JOCU

Primary DI
B3385PB16301
Brand
EACU, EAKU, ZAGU, JOCU
Company
Maanshan Bond Medical Instruments Co., Ltd.
Model
5PB1630
Published
2024-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150903000EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral NaturalMaanshan Bond Medical Instruments Co., Ltd.2015-07-15MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3385PB16302PackageHIBCC10In Commercial Distribution
B3385PB16301PrimaryHIBCC0
B3385PB16300Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture needle, single-useA sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.

Regulatory Flags#

DUNS number
421257620
Device count
500
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3385PB12151EACU, EAKU, ZAGU, JOCU5PB12152026-04-14
B3385PB12301EACU, EAKU, ZAGU, JOCU5PB12302026-04-14
B3385PB20151EACU, EAKU, ZAGU, JOCU5PB20152026-04-14
B3385PB22151EACU, EAKU, ZAGU, JOCU5PB22152026-04-14
B338J16151EACU, EAKU, ZAGU, JOCUJ16152026-04-14
B3385PB14151EACU, EAKU, ZAGU, JOCU5PB14152024-01-11
B3385PB14301EACU, EAKU, ZAGU, JOCU5PB14302024-01-11
B3385PB16151EACU, EAKU, ZAGU, JOCU5PB16152024-01-11
B3385PB18151EACU, EAKU, ZAGU, JOCU5PB18152024-01-11
B3385PB18301EACU, EAKU, ZAGU, JOCU5PB18302024-01-11
B3385PB20301EACU, EAKU, ZAGU, JOCU5PB20302024-01-11
B3385PB22301EACU, EAKU, ZAGU, JOCU5PB22302024-01-11
B3385PB22401EACU, EAKU, ZAGU, JOCU5PB22402024-01-11
B3385PB25301EACU, EAKU, ZAGU, JOCU5PB25302024-01-11
B3385PB25401EACU, EAKU, ZAGU, JOCU5PB25402024-01-11
B3385PB25501EACU, EAKU, ZAGU, JOCU5PB25502024-01-11
B3385PB14152EACU, EAKU, ZAGU, JOCU5PB14152024-01-11
B3385PB14300EACU, EAKU, ZAGU, JOCU5PB14302024-01-11
B3385PB16152EACU, EAKU, ZAGU, JOCU5PB16152024-01-11
B3385PB16302EACU, EAKU, ZAGU, JOCU5PB16302024-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810202812642TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812666TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812680TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812703TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812727TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812741TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812765TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812789TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812802TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812826TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812840TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812864TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812888TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812901TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812925TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812956TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812970TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812994TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813014TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813038TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813052TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813076TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813090TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813113TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813137TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813151TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813175TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813199TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813212TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813236TCMzone HuaTuoTCMZone, LLCMQX2026-08-01