DEVICE: TCMzone HuoTuo (00860014142451)
Device Identifier (DI) Information
TCMzone HuoTuo
TIK-0.25mm x 40mm
In Commercial Distribution
TIK-0.25mm x 40mm (#32)
TCMZone, LLC
TIK-0.25mm x 40mm
In Commercial Distribution
TIK-0.25mm x 40mm (#32)
TCMZone, LLC
Disposable acupuncture needle, 0.25mm × 40mm (#32), with spring handle and guide tube. Sterile, single-use.
Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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34175 | Acupuncture needle, single-use |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MQX | Needle, Acupuncture, Single Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9d46e78b-ea00-43ee-bff3-07738be52237
July 08, 2025
1
June 30, 2025
July 08, 2025
1
June 30, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00860014142499
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined