FDA UDI
In Commercial Distribution
🇺🇸 United States
IDryNeedle 0.45x105
DI: 18809407787663
·
Model: DN161 0.45x105
·
Feeltech Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- IDryNeedle 0.45x105
- Primary DI
- 18809407787663
- Version / Model
- DN161 0.45x105
- Company Name
- Feeltech Co.,Ltd.
- Labeler DUNS
- 688432407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-07-17
- Public Version
- 1
- Public Version Date
- 2020-07-27
- Public Version Status
- New
- Public Device Record Key
- 3625f3e4-c1a9-491c-b8bd-61e9af00b630
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 28809407787660 | GS1 | CARTON BOX | 10000 | In Commercial Distribution | |
| Primary | 18809407787663 | GS1 | ||||
| Unit of Use | 08809407780018 | GS1 |