FDA UDI
In Commercial Distribution
🇺🇸 United States
AcuZone
DI: B491AZ30605
·
Model: AZ-3060
·
Wujiang City ShenLing Medical Device Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
Basic Information
- Brand Name
- AcuZone
- Primary DI
- B491AZ30605
- Version / Model
- AZ-3060
- Catalog Number
- AZ-3060
- Company Name
- Wujiang City ShenLing Medical Device Co.,Ltd
- Labeler DUNS
- 654613546
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2017-12-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- ee6ac3ab-2220-4da4-9309-be885f33384d
Device Description
Smooth and sharp for painless, AcuZone disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is without loop. Steriliized with Ethylene Oxide, This is a bulk pack offering a more economical price. 10 needles with one (insertion) guide tube per sterile, individually sealed blister package. Box of 1000 needles. 0.30mm x 60mm (30# x 2.5").
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 | B491AZ30607 | HIBCC | 10 | In Commercial Distribution | ||
| Primary | B491AZ30605 | HIBCC | ||||
| Unit of Use | B491AZ130600 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Needle Size 0.30mm x 60mm |