FDA UDI
In Commercial Distribution
🇺🇸 United States
HBW HI.CHI
DI: 00816073022982
·
Model: HP Type No.30G x 50mm
·
HEALTH BODY WORLD SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- HBW HI.CHI
- Primary DI
- 00816073022982
- Version / Model
- HP Type No.30G x 50mm
- Catalog Number
- HP3020
- Company Name
- HEALTH BODY WORLD SUPPLY, INC.
- Labeler DUNS
- 061228290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-09-09
- Public Version
- 1
- Public Version Date
- 2019-09-17
- Public Version Status
- New
- Public Device Record Key
- 8bebc8ae-4b39-4cc8-938d-0d504acf7333
Device 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: 30G x 50mm.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQX | Needle, Acupuncture, Single Use | General Hospital | 880.5580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816073022982 | GS1 | ||||
| Unit of Use | 10816073022989 | GS1 |
Customer Contacts
- Phone
- 800-852-4609
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.20 x 30mm |