FDA UDI
In Commercial Distribution
🇺🇸 United States
SHUNLI
DI: 00815005021147
·
Model: 0.20*25
·
Wuxi Jiajian Medical Instrument Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SHUNLI
- Primary DI
- 00815005021147
- Version / Model
- 0.20*25
- Company Name
- Wuxi Jiajian Medical Instrument Co.,Ltd.
- Labeler DUNS
- 529966489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-25
- Public Version
- 4
- Public Version Date
- 2021-09-10
- Public Version Status
- Update
- Public Device Record Key
- 0fedaf22-baa5-40f8-b499-7e5fdc975494
Device Description
SHUNLI Stainless spring handle Singles Acupuncture Needles are sterile disposable. The needle length is 25mm length. One needle with one insertion tube per sterile, individually sealed blister package. Needles are secured in guide tubes with plastic holding tabs. 200 needles per box.
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
- Yes
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 | 00815005021147 | GS1 |