FDA UDI
In Commercial Distribution
🇺🇸 United States
Hwa-To Five Acupuncture Needles
DI: 16901452940030
·
Model: 0.25x13
·
Suzhou Medical Appliance Factory
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- Hwa-To Five Acupuncture Needles
- Primary DI
- 16901452940030
- Version / Model
- 0.25x13
- Catalog Number
- Hf.25x13
- Company Name
- Suzhou Medical Appliance Factory
- Labeler DUNS
- 653739474
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2018-12-31
- Public Version Status
- Update
- Public Device Record Key
- 74ba98b8-8b93-4572-96ff-9728eabf12b0
Device Description
Hwato® Five Acupuncture Needles. Bulk-5 Packs. Silver plated copper handle needle with guide tube, 200 needles with 24 tubes.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 36901452940034 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 16901452940030 | GS1 | ||||
| Unit of Use | 06901452940033 | GS1 |
Customer Contacts
- Phone
- 18007228775
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.25x13mm |