FDA UDI
In Commercial Distribution
🇺🇸 United States
HWATO Yuezhen - ACA COMFORT NEEDLE
DI: 16901452648035
·
Model: 0.22X13
·
Suzhou Medical Appliance Factory
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
Basic Information
- Brand Name
- HWATO Yuezhen - ACA COMFORT NEEDLE
- Primary DI
- 16901452648035
- Version / Model
- 0.22X13
- Company Name
- Suzhou Medical Appliance Factory
- Labeler DUNS
- 653739474
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2017-05-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- aafcd005-f0fb-42d2-b7b5-ee8f03f40066
Device Description
HWATO Yuezhen - ACA COMFORT NEEDLE, sterile, disposable, and surgical stainless steel Acupuncture Needles with spring style stainless steel handle. Bulk pack with 10 needles and one insertion tube per sterile, individually sealed package. Box of 1000 needles.
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 |
|---|---|---|---|---|---|---|
| Primary | 16901452648035 | GS1 | ||||
| Unit of Use | 06901452648038 | GS1 | ||||
| Package | 36901452648039 | GS1 | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974122 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.22X13mm |