FDA.reportPublic FDA data

HUAN QIU Acupuncture needle

Primary DI
26956418902185
Brand
HUAN QIU Acupuncture needle
Company
Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
Model
0.30×75mm
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
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
26956418902185PackageGS1100In Commercial Distribution
16956418902188PrimaryGS10
06956418902181Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2695641890218526956418902185
1695641890218816956418902188
06956418902181069564189021816956418902181

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
100
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810202812642TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
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00810202812741TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812765TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812789TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
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00810202812826TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
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00810202812864TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
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00810202812970TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
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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
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00810202813151TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
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00810202813199TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813212TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813236TCMzone HuaTuoTCMZone, LLCMQX2026-08-01