FDA UDI
In Commercial Distribution
🇺🇸 United States
SEIRIN ACUPUNCTURE NEEDLE
DI: 04547248244644
·
Model: KB-Type No.10(0.35)x150mm
·
SEIRIN CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- SEIRIN ACUPUNCTURE NEEDLE
- Primary DI
- 04547248244644
- Version / Model
- KB-Type No.10(0.35)x150mm
- Company Name
- SEIRIN CORPORATION
- Labeler DUNS
- 693307373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-07-31
- Public Version
- 1
- Public Version Date
- 2025-08-08
- Public Version Status
- New
- Public Device Record Key
- 69828a82-937f-4b46-ac37-cd15dc4868c7
Device Description
Metal Handle with Guide Tube
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
- 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 | 14547248244641 | GS1 | BOX | 4 | In Commercial Distribution | |
| Primary | 04547248244644 | GS1 | ||||
| Unit of Use | 24547248244648 | GS1 |
Customer Contacts
- Phone
- 800 722 8775
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Millimeter | |
| Outer Diameter | 0.35 | Millimeter |