FDA.reportPublic FDA data

EACU, EAKU, ZAGU, JOCU

Primary DI
B3385PB22401
Brand
EACU, EAKU, ZAGU, JOCU
Company
Maanshan Bond Medical Instruments Co., Ltd.
Model
5PB2240
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
B3385PB22402PackageHIBCC10In Commercial Distribution
B3385PB22401PrimaryHIBCC0
B3385PB22400Unit 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
B3385PB16301EACU, EAKU, ZAGU, JOCU5PB16302024-01-11
B3385PB18151EACU, EAKU, ZAGU, JOCU5PB18152024-01-11
B3385PB18301EACU, EAKU, ZAGU, JOCU5PB18302024-01-11
B3385PB20301EACU, EAKU, ZAGU, JOCU5PB20302024-01-11
B3385PB22301EACU, EAKU, ZAGU, JOCU5PB22302024-01-11
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
00807689000365LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000372LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000389LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000396LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000402LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000419LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000426LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000433LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000440LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000457LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000464LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000471LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000488LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000495LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000501LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000518LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000525LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000532LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000549LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000556LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000563LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000570LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000587LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000594LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000600LEKONC A I INDUSTRIES CORPMQX2026-07-11
B5171004580Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
B517100458010Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
00816073022487SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023347HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023354HyChiHealth Body World Supply Inc.MQX2026-06-23