FDA UDI
In Commercial Distribution
🇺🇸 United States
SMC acupuncture needle
DI: 08800020300201
·
Model: 02003025
·
SMC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
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Basic Information
- Brand Name
- SMC acupuncture needle
- Primary DI
- 08800020300201
- Version / Model
- 02003025
- Company Name
- SMC
- Labeler DUNS
- 689846232
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7f25a6d2-52df-47a9-94fc-ef2b147b8a72
Device Description
SMC acupuncture needle 0.20*30 (1,000pcs/Box) 25mm Handle SMC's sterile, disposable, and surgical stainless steel acupuncture needles with style handle. Due to its automated manufactering procedure, the needle provides the consistancy in its quality.
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
- No
- 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 | 08800020300430 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 08800020300201 | GS1 | ||||
| Unit of Use | 88800020300207 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141473 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.20*30 (1,000pcs/Box) 25mm Handle |