FDA UDI
In Commercial Distribution
🇺🇸 United States
IDryNeedle 0.30x40
DI: 18800145508374
·
Model: DNC150 0.30x40
·
Feeltech Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Basic Information
- Brand Name
- IDryNeedle 0.30x40
- Primary DI
- 18800145508374
- Version / Model
- DNC150 0.30x40
- Company Name
- Feeltech Co.,Ltd.
- Labeler DUNS
- 688432407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-05-09
- Public Version
- 1
- Public Version Date
- 2024-05-17
- Public Version Status
- New
- Public Device Record Key
- 45cf0eea-6e38-4fda-861d-ed374ce6d15e
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
- 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 | 28800145508371 | GS1 | outbox | 1000 | In Commercial Distribution | |
| Primary | 18800145508374 | GS1 | ||||
| Package | 38800145508378 | GS1 | carton box | 20000 | In Commercial Distribution | |
| Unit of Use | 08800145508377 | GS1 |