FDA UDI
In Commercial Distribution
🇺🇸 United States
TEWA
DI: 04251282511029
·
Model: CJ-Type 3575 Safe-T Sleeve
·
asia-med GmbH
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Basic Information
- Brand Name
- TEWA
- Primary DI
- 04251282511029
- Version / Model
- CJ-Type 3575 Safe-T Sleeve
- Catalog Number
- A000486
- Company Name
- asia-med GmbH
- Labeler DUNS
- 333450844
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2017-11-30
- Public Version
- 4
- Public Version Date
- 2023-03-27
- Public Version Status
- Update
- Public Device Record Key
- 4c495fa4-fe63-49ab-97af-1f44b34c8d6b
Device Description
TeWa CJ-Type 3575 Safe-T Sleeve: coated acupuncture needles with copper-wire handle|with Safe-T Sleeve guide tube|Packaging: 1 needle per blister|Size: Gauge 10(x 3.0") / 0.35 x 75 mm|Color code: black|Sales unit: 100 pieces
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
- 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 |
|---|---|---|---|---|---|---|
| Previous | 04251282503703 | GS1 | ||||
| Package | 04251282511036 | GS1 | parcel | 10 | In Commercial Distribution | |
| Primary | 04251282511029 | GS1 | ||||
| Unit of Use | 04251282511012 | GS1 |
Customer Contacts
- Phone
- +49897473150
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 75 | Millimeter | |
| Outer Diameter | 0.35 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 25 Degrees Celsius