FDA UDI
In Commercial Distribution
🇺🇸 United States
HBW SILVERSTAR
DI: 00816073020797
·
Model: S Type No.38G x 13mm(0.5")
·
HEALTH BODY WORLD SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- HBW SILVERSTAR
- Primary DI
- 00816073020797
- Version / Model
- S Type No.38G x 13mm(0.5")
- Catalog Number
- S3805
- Company Name
- HEALTH BODY WORLD SUPPLY, INC.
- Labeler DUNS
- 061228290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2019-06-26
- Public Version
- 1
- Public Version Date
- 2019-07-04
- Public Version Status
- New
- Public Device Record Key
- 0bdf8f59-51f1-4226-b0fc-1991adedd1d1
Device Description
Sterile, disposable, High quality surgical stainless steel Chinese style acupuncture needles with spiral wound silver plated copper handle. smoothly and painless. 5 needles per guide tube. Box of 500. Size:38Gauge x 13mm (0.5")
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 | 00816073020797 | GS1 | ||||
| Unit of Use | 10816073020794 | GS1 |
Customer Contacts
- Phone
- 800-852-4609
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.18 x 13mm |