FDA.reportPublic FDA data

YI SHEN BIAN QUE Acupuncture needle

Primary DI
16956418959120
Brand
YI SHEN BIAN QUE Acupuncture needle
Company
Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
Model
0.30×30mm
Device description
Stainless steel flat handle acupuncture needle, five needles+1tube in one blister,500pcs/box.
Published
2019-03-15
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
K011242000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011242000HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USEAcusupply, Inc.2001-09-11MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26956418959127PackageGS150In Commercial Distribution
16956418959120PrimaryGS10
06956418959123Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2695641895912726956418959127
1695641895912016956418959120
06956418959123069564189591236956418959123

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
527023772
Device count
500
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16956418969686HUAN QIU Acupuncture needle0.40×300mm2019-04-28
26956418969683HUAN QIU Acupuncture needle0.40×300mm2019-04-28
16956418969679YI SHEN BIAN QUE Acupuncture needle0.15×20mm2019-03-18
26956418969676YI SHEN BIAN QUE Acupuncture needle0.15×20mm2019-03-18
16956418902164HUAN QIU Acupuncture needle0.30×60mm2019-03-15
16956418902188HUAN QIU Acupuncture needle0.30×75mm2019-03-15
16956418902546HUAN QIU Acupuncture needle0.35×100mm2019-03-15
16956418958321YI SHEN BIAN QUE Acupuncture needle0.16×15mm2019-03-15
16956418958468YI SHEN BIAN QUE Acupuncture needle0.18×20mm2019-03-15
16956418958567YI SHEN BIAN QUE Acupuncture needle0.20×20mm2019-03-15
16956418958574YI SHEN BIAN QUE Acupuncture needle0.20×25mm2019-03-15
16956418958581YI SHEN BIAN QUE Acupuncture needle0.20×30mm2019-03-15
16956418958666YI SHEN BIAN QUE Acupuncture needle0.22×20mm2019-03-15
16956418958673YI SHEN BIAN QUE Acupuncture needle0.22×25mm2019-03-15
16956418958789YI SHEN BIAN QUE Acupuncture needle0.25×30mm2019-03-15
16956418958796YI SHEN BIAN QUE Acupuncture needle0.25×40mm2019-03-15
16956418959144YI SHEN BIAN QUE Acupuncture needle0.30×50mm2019-03-15
16956418959151YI SHEN BIAN QUE Acupuncture needle0.30×60mm2019-03-15
16956418969488YI SHEN BIAN QUE Acupuncture needle0.22×20mm2019-03-15
16956418969495YI SHEN BIAN QUE Acupuncture needle0.22×30mm2019-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00807689000464LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000471LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000488LEKONC A I INDUSTRIES CORPMQX2026-07-11
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00807689000532LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000549LEKONC A I INDUSTRIES CORPMQX2026-07-11
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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
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