FDA UDI
In Commercial Distribution
🇺🇸 United States
Gold Tai Chi™
DI: 16970514320448
·
Model: AY8601
·
Suzhou Shenlong Medical Apparatus Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Gold Tai Chi™
- Primary DI
- 16970514320448
- Version / Model
- AY8601
- Catalog Number
- AY8601
- Company Name
- Suzhou Shenlong Medical Apparatus Co., Ltd.
- Labeler DUNS
- 545745192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-07-26
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 637d95a6-637a-4a22-b59d-38dea62d535b
Device Description
High quality, painless, sterile, gold plated, surgical stainless steel Chinese acupuncture needles with spiral wound gold plated copper handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100, 0.16x13 mm.
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 | 36970514320442 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 16970514320448 | GS1 | ||||
| Unit of Use | 06970514320441 | GS1 |
Customer Contacts
- Phone
- 800-722-8775
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023787 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.16x13 mm |