FDA.reportPublic FDA data

TCMzoneHuaTuo

Primary DI
00810202812536
Brand
TCMzoneHuaTuo
Company
TCMZone, LLC
Model
T1K Type 0.18mm x 15mm
Device description
T1K Type Acupuncture Needle, 0.18mm x 15mm, 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
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
00810202812536PrimaryGS10
00810202812529Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810202812536008102028125368102028125360810202812536
00810202812529008102028125298102028125290810202812529

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
007842633
Device count
1000
Premarket exempt
true
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
00810202812642TCMzone HuaTuoT5C 20252026-08-01
00810202812666TCMzone HuaTuoT5C 22252026-08-01
00810202812680TCMzone HuaTuoT5C16252026-08-01
00810202812703TCMzone HuaTuoT5C18252026-08-01
00810202812727TCMzone HuaTuoT5C22402026-08-01
00810202812741TCMzone HuaTuoT5C20402026-08-01
00810202812765TCMzone HuaTuoT5C25402026-08-01
00810202812789TCMzone HuaTuoT5C18132026-08-01
00810202812802TCMzone HuaTuoT5C16132026-08-01
00810202812826TCMzone HuaTuoT5C14132026-08-01
00810202812840TCMzone HuaTuoT5C25252026-08-01
00810202812864TCMzone HuaTuoT5C25752026-08-01
00810202812888TCMzone HuaTuoT5C30752026-08-01
00810202812901TCMzone HuaTuoT5C12132026-08-01
00810202812925TCMzone HuaTuoT5C40502026-08-01
00810202812956TCMzone HuaTuoT5C14252026-08-01
00810202812970TCMzone HuaTuoT5C40402026-08-01
00810202812994TCMzone HuaTuoT5C40752026-08-01
00810202813014TCMzone HuaTuoT5C20132026-08-01
00810202813038TCMzone HuaTuoT5C22752026-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00768627017503Red RubyNORTH COAST MEDICAL, INC.MQX2026-10-01
00768627017510Red RubyNORTH COAST MEDICAL, INC.MQX2026-10-01
00768627017527Red RubyNORTH COAST MEDICAL, INC.MQX2026-10-01
00768627017534Red RubyNORTH COAST MEDICAL, INC.MQX2026-10-01
00818318024027Alpha™ Acupuncture NeedlesPrime Holly CorporationMQX2026-09-10
00818318024126Alpha™ Acupuncture NeedlesPrime Holly CorporationMQX2026-09-10
00810202812642TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812666TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812680TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812703TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812727TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812741TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812765TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812789TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812802TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812826TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812840TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812864TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812888TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812901TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812925TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812956TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812970TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812994TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
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
00810202813113TCMzone HuaTuoTCMZone, LLCMQX2026-08-01