FDA.reportPublic FDA data

HUAN QIU Acupuncture needle

Primary DI
16956418902164
Brand
HUAN QIU Acupuncture needle
Company
Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
Model
0.30×60mm
Device description
Stainless steel flat handle acupuncture needle, one needle with one tube in one blister,100pcs/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
26956418902161PackageGS1100In Commercial Distribution
16956418902164PrimaryGS10
06956418902167Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2695641890216126956418902161
1695641890216416956418902164
06956418902167069564189021676956418902167

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
100
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
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
16956418959120YI SHEN BIAN QUE Acupuncture needle0.30×30mm2019-03-15
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
00816073022500HBW PINEHealth Body World Supply Inc.MQX2020-10-19
00816073022630HBW UNISHARPHealth Body World Supply Inc.MQX2019-07-12
00816073020797HBW SILVERSTARHealth Body World Supply Inc.MQX2019-06-26
00816073022616HBW PINEHealth Body World Supply Inc.MQX2019-04-15
00816073022470HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022524HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022531HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022548HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022555HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022562HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022579HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022586HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022609HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022395SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022401SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022166HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022319HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022326HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022333HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022340HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022036HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022050HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022067HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022074HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022098HBW DETOX NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022296HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022302HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022043HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073021244HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10
00816073021251HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10