FDA.reportPublic FDA data

TCMzoneHuaTuo

Primary DI
00810202810334
Brand
TCMzoneHuaTuo
Company
TCMZone, LLC
Model
T1K Type 0.16mm x 15mm
Device description
T1K Type Acupuncture Needle, 0.16mm 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
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
00810202810327PrimaryGS10
00810202810334Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810202810327008102028103278102028103270810202810327
00810202810334008102028103348102028103340810202810334

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
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