FDA.reportPublic FDA data

TCMzoneHuaTuo

Primary DI
00810202812444
Brand
TCMzoneHuaTuo
Company
TCMZone, LLC
Model
T1K Type 0.20mm x 50mm
Device description
T1K Type Acupuncture Needle, 0.20mm x 50mm, Spring Handle, Guide Tube, 10 needles/blister, 1000 needles/box
Published
2025-08-20
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810202812451PrimaryGS10
00810202812444Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810202812451008102028124518102028124510810202812451
00810202812444008102028124448102028124440810202812444

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
007842633
Device count
1000
DM exempt
false
Premarket exempt
true
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
00810202810327TCMzoneHuaTuoT1K Type 0.16mm x 15mm2025-08-20
00810202812451TCMzoneHuaTuoT1K Type 0.20mm x 50mm2025-08-20
00810202812475TCMzoneHuaTuoT1K Type 0.20mm x 15mm2025-08-20
00810202812499TCMzoneHuaTuoT1K Type 0.18mm x 40mm2025-08-20
00810202812512TCMzoneHuaTuoT1K Type 0.18mm x 30mm2025-08-20
00810202812536TCMzoneHuaTuoT1K Type 0.18mm x 15mm2025-08-20
00810202812550TCMzoneHuaTuoT1K Type 0.16mm x 40mm2025-08-20
00810202812574TCMzoneHuaTuoT1K Type 0.16mm x 30mm2025-08-20
00810202810334TCMzoneHuaTuoT1K Type 0.16mm x 15mm2025-08-20
00810202812468TCMzoneHuaTuoT1K Type 0.20mm x 15mm2025-08-20
00810202812482TCMzoneHuaTuoT1K Type 0.18mm x 40mm2025-08-20
00810202812505TCMzoneHuaTuoT1K Type 0.18mm x 30mm2025-08-20
00810202812529TCMzoneHuaTuoT1K Type 0.18mm x 15mm2025-08-20
00810202812543TCMzoneHuaTuoT1K Type 0.16mm x 40mm2025-08-20
00810202812567TCMzoneHuaTuoT1K Type 0.16mm x 30mm2025-08-20
00810202812215TCMzoneHuaTuoT1K Type 0.30mm x 60mm2025-08-16
00810202812239TCMzoneHuaTuoT1K Type 0.30mm x 50mm2025-08-16
00810202812253TCMzoneHuaTuoT1K Type 0.30mm x 40mm2025-08-16
00810202812277TCMzoneHuaTuoT1K Type 0.30mm x 30mm2025-08-16
00810202812291TCMzoneHuaTuoT1K Type 0.30mm x 15mm2025-08-16

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