ASP
- Primary DI
- 03760262490441
- Brand
- ASP
- Company
- SEDATELEC
- Model
- ASPG200
- Catalog number
- 110615
- Device description
- The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.The ASP Gold steel needle, with a film of pure Gold, is for use with patients who are allergic.
- Published
- 2016-09-22
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| MQX | Needle, Acupuncture, Single Use |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MQX | Needle, Acupuncture, Single Use | General Hospital | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K060392 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 03760262490441 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 03760262490441 | 03760262490441 | 3760262490441 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Humidity | 0 Percent (%) Relative Humidity | 70 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 0 Degrees Celsius | 40 Degrees Celsius |
Contacts#
| Phone | |
|---|---|
| +33472663322 | contact@sedatelec.com |
Regulatory Flags#
- DUNS number
- 266031462
- Device count
- 1
- DM exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 03760262493107 | PREMIO 10 MOXA | PREMIO 10 | 111237 | 2016-09-22 |
| 03760262490625 | BAT02 Glass rods | BAT02 | 103607 | 2024-04-25 |
| 03760262490670 | EASYO 1 - Multi Pressure Feeler | EASYO 1 | 112353 | 2024-04-25 |
| 03760262492902 | PAL130 Pressure feeler 130g | PAL130 | 103609 | 2024-04-25 |
| 03760262492919 | PAL250 Pressure feeler 250g | PAL250 | 103304 | 2024-04-25 |
| 03760262492926 | PAL400 Pressure feeler 400g | PAL400 | 103610 | 2024-04-25 |
| 03760262492933 | PAL650 Pressure feeler 650g | PAL650 | 103611 | 2024-04-25 |
| 03760262490557 | ASP | ASPTEST | 110640 | 2023-01-12 |
| 03760262493404 | ASP | ASPMA320 | 113201 | 2023-01-12 |
| 03760262493411 | ASP | ASPMG320 | 113202 | 2023-01-12 |
| 03760262493428 | ASP | ASPMT320 | 113203 | 2023-01-12 |
| 03760262493435 | ASP | ASPMA120 | 113204 | 2023-01-12 |
| 03760262493442 | ASP | ASPMG120 | 113205 | 2023-01-12 |
| 03760262493459 | ASP | ASPMT120 | 113206 | 2023-01-12 |
| 03760262493466 | ASP | ASPMTEST | 113207 | 2023-01-12 |
| 03760262493473 | ASP | ASPA64 | 113208 | 2023-01-12 |
| 03760262493480 | ASP | ASPG64 | 113209 | 2023-01-12 |
| 03760262493497 | ASP | ASPT64 | 113210 | 2023-01-12 |
| 03760262490427 | ASP | ASPA8 | 110636 | 2016-09-22 |
| 03760262490465 | ASP | ASPG8 | 110637 | 2016-09-22 |
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| 00816073022524 | HBW UNISHARP | Health Body World Supply Inc. | MQX | 2019-03-08 |
| 00816073022531 | HBW UNISHARP | Health Body World Supply Inc. | MQX | 2019-03-08 |
| 00816073022548 | HBW UNISHARP | Health Body World Supply Inc. | MQX | 2019-03-08 |
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| 00816073022579 | HBW UNISHARP | Health Body World Supply Inc. | MQX | 2019-03-08 |
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| 00816073022395 | SILVERSTAR | Health Body World Supply Inc. | MQX | 2018-04-14 |
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| 00816073022050 | HBW 7 STAR NEEDLES | Health Body World Supply Inc. | MQX | 2016-09-27 |
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