FDA UDI
In Commercial Distribution
🇺🇸 United States
Balance 1KS Acupuncture Needle
DI: 10854166000629
·
Model: Balance 1KS-Type 1615
·
BLUE POPPY ENTERPRISES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- Balance 1KS Acupuncture Needle
- Primary DI
- 10854166000629
- Version / Model
- Balance 1KS-Type 1615
- Company Name
- BLUE POPPY ENTERPRISES INC.
- Labeler DUNS
- 080493003
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2019-01-07
- Public Version
- 1
- Public Version Date
- 2019-02-07
- Public Version Status
- New
- Public Device Record Key
- b80dccb0-6c84-43e2-93fa-eb4b7b2fb887
Device Description
Featuring a traditional “spring” style handle that comes in blister packs of 10 needles and one guide tube, the Balance 1KS 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 | 10854166000629 | GS1 | ||||
| Unit of Use | 30854166000623 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150903 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15 | Millimeter | |
| Outer Diameter | 0.16 | Millimeter |