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Asp

FDA UDI

Class II (US FDA UDI)

by Sedatelec

Identity

Trade Name
ASP FDA UDI
Generic Name
Acupuncture needle, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
ASPGSOLO25 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
110634 FDA UDI
Primary DI / UDI-DI
03760262490472 FDA UDI
510(k) Number
K060392 FDA UDI
FDA Product Code
MQX FDA UDI
GMDN Term
Acupuncture needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5580 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Asp by Sedatelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K060392 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sedatelec

Sources (1)

  • FDA UDI d6a273db-4444-4081-839b-d5834ba5f0c1 38 fields · synced Jun 8, 2026