FDA UDI
In Commercial Distribution
🇺🇸 United States
SEIRIN ACUPUNCTURE NEEDLE
DI: 04547248176150
·
Model: D-Type (D-Kaede) No.2(0.18)x15mm
·
SEIRIN CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- SEIRIN ACUPUNCTURE NEEDLE
- Primary DI
- 04547248176150
- Version / Model
- D-Type (D-Kaede) No.2(0.18)x15mm
- Company Name
- SEIRIN CORPORATION
- Labeler DUNS
- 693307373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-04-18
- Public Version
- 1
- Public Version Date
- 2024-04-26
- Public Version Status
- New
- Public Device Record Key
- aa82f446-a4f6-4f2e-86e1-58836b993844
Device Description
SEIRIN D-Type needles are a perfect choice for gentle, painless and stress-free acupuncture treatments where shallow needling is performed. Similar in style to the J-Type, the D-Type needle is available only in a length of 15 mm and does not have guide tubes, which make it ideal for freehand techniques. The color-coded 2.0 x 20 mm plastic handle gives the practitioner a secure grip. Box of 100 sterile, disposable 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
- 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 | 14547248176157 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 04547248176150 | GS1 | ||||
| Unit of Use | 24547248176154 | GS1 |
Customer Contacts
- Phone
- 800 722 8775
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15 | Millimeter | |
| Outer Diameter | 0.18 | Millimeter |