FDA.reportPublic FDA data

TCMzoneHuaTuo

Primary DI
00810202812291
Brand
TCMzoneHuaTuo
Company
TCMZone, LLC
Model
T1K Type 0.30mm x 15mm
Device description
T1K Type Acupuncture Needle, 0.30mm x 15mm, Spring Handle, Guide Tube, 10 needles/blister, 1000 needles/box
Published
2025-08-16
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
00810202812291PrimaryGS10
00810202812284Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810202812291008102028122918102028122910810202812291
00810202812284008102028122848102028122840810202812284

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
No natural rubber latex
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