FDA UDI
In Commercial Distribution
🇺🇸 United States
Fine Point Acupuncture Needle
DI: 00818318020548
·
Model: T1 Type 0.22 x 50 mm
·
Prime Holly Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- Fine Point Acupuncture Needle
- Primary DI
- 00818318020548
- Version / Model
- T1 Type 0.22 x 50 mm
- Catalog Number
- NFT1-3420
- Company Name
- Prime Holly Corporation
- Labeler DUNS
- 080445043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2017-03-15
- Public Version
- 6
- Public Version Date
- 2023-11-08
- Public Version Status
- Update
- Public Device Record Key
- f67ca2ce-b085-47c7-b584-f2243b109cf1
Device Description
Fine Point Acupuncture Needles, Sterile, Surgical Stainless steel acupuncture needle body, One needle per tube, 200 needles per box.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 | 10818318020545 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00818318020548 | GS1 | ||||
| Unit of Use | 20818318020542 | GS1 |
Customer Contacts
- Phone
- 4085739889
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.22 x 50 mm |