Identity
- Trade Name
- HBW HI.CHI FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- The ergonomically optimized and precisely centered handle ensures safe and convenient use. Measuring 2.0 x 20 mm, the handle is made of extremely lightweight and environmentally-friendly polypropylene plastic with Color-coded handles for easy gauge identification. Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube, easy peel-open blister packaging. The needle is made of the highest quality surgical stainless steel. At the tip, it is filed to diamond sharpness and polished, making insertion particularly easy for the therapist and practically painless for the patient. Box of 100. Size: 36G x 40mm. FDA UDI
- Model / Reference
- HP Type No.36G x 40mm FDA UDI
- Description
- The ergonomically optimized and precisely centered handle ensures safe and convenient use. Measuring 2.0 x 20 mm, the handle is made of extremely lightweight and environmentally-friendly polypropylene plastic with Color-coded handles for easy gauge identification. Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube, easy peel-open blister packaging. The needle is made of the highest quality surgical stainless steel. At the tip, it is filed to diamond sharpness and polished, making insertion particularly easy for the therapist and practically painless for the patient. Box of 100. Size: 36G x 40mm. FDA UDI
Identifiers
- Catalog Number
- HP3615 FDA UDI
- Primary DI / UDI-DI
- 00816073021817 FDA UDI
- FDA Product Code
- MQX FDA UDI
- GMDN Term
- Acupuncture needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acupuncture needle, single-use
Hbw Hi.chi by Health Body World Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Health Body World Supply, Inc.
Sources (1)
- FDA UDI eb2d794a-a7e1-485e-96d7-2df80a2b7f40 36 fields · synced May 30, 2026