FDA.reportPublic FDA data

YI SHEN BIAN QUE Acupuncture needle

Primary DI
26956418969676
Brand
YI SHEN BIAN QUE Acupuncture needle
Company
Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
Model
0.15×20mm
Device description
Stainless steel flat handle acupuncture needle, five needles+1tube in one blister,500pcs/box.
Published
2019-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
26956418969676PackageGS150In Commercial Distribution
16956418969679PrimaryGS10
06956418969672Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2695641896967626956418969676
1695641896967916956418969679
06956418969672069564189696726956418969672

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527023772
Device count
500
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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