Duns Number:266031462
Device Description: The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needl 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 Titanium is a massive medical grade 4 titanium needle, it has a maximum level of biocompatibility. It is for use with high-risk patient: diabetic, immunodeficient or with multiple allergies. It can be stay in place during MRI examination.
Catalog Number
110616
Brand Name
ASP
Version/Model Number
ASPT200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2016
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060392
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
941f0777-c330-4236-bf05-81fdd06c5379
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |