FDA.reportPublic FDA data

TCMzoneHuaTuo

Primary DI
00810202812512
Brand
TCMzoneHuaTuo
Company
TCMZone, LLC
Model
T1K Type 0.18mm x 30mm
Device description
T1K Type Acupuncture Needle, 0.18mm x 30mm 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
00810202812512PrimaryGS10
00810202812505Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810202812512008102028125128102028125120810202812512
00810202812505008102028125058102028125050810202812505

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
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
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
00810202812444TCMzoneHuaTuoT1K Type 0.20mm x 50mm2025-08-20
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
08437016482285AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482292AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482308AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482315AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482322AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482339AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482407AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482414AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482421AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482438AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482445AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482452AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482469AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482476AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482483AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482490AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482506AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482513AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482520AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482537AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482551AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482568AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482575AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482582AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482599AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482605AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482612AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482629AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482636AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482643AGUPUNT APSAGU PUNT SLMQX2022-04-27