FDA UDI
In Commercial Distribution
🇺🇸 United States
Balance SL-Type Acupuncture Needle
DI: 10854166000506
·
Model: Balance SL-Type 1840
·
BLUE POPPY ENTERPRISES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Balance SL-Type Acupuncture Needle
- Primary DI
- 10854166000506
- Version / Model
- Balance SL-Type 1840
- Company Name
- BLUE POPPY ENTERPRISES INC.
- Labeler DUNS
- 080493003
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-01-10
- Public Version
- 1
- Public Version Date
- 2019-02-11
- Public Version Status
- New
- Public Device Record Key
- 3c2d5099-755d-4c79-96a2-c7b63b44e934
Device Description
Featuring a traditional “Spiral & Loop” style handle that comes one guide tube per needle, the Balance SL-Type is an achievement in combining the highest quality with unprecedented value.
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Primary | 10854166000506 | GS1 | ||||
| Unit of Use | 30854166000500 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150903 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 40 | Millimeter | |
| Outer Diameter | 0.18 | Millimeter |