Identity
- Trade Name
- APS Dry Needling Neeedles FDA UDI
- Generic Name
- Dry-needling needle FDA UDI
- Model / Reference
- A1038P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437016482056 FDA UDI
- 510(k) Number
- K003748 FDA UDI
- FDA Product Code
- MQX FDA UDI
- GMDN Term
- Dry-needling needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Dry-needling needle
APS Dry Needling Neeedles by Agu Punt Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dry-needling needle.
- APS Dry Needling Neeedles — AGU PUNT SL · Class II
- AGUPUNT APS — AGU PUNT SL · Class II
- AGUPUNT APS — AGU PUNT SL · Class II
- AGUPUNT APS — AGU PUNT SL · Class II
- APS Dry Needling Neeedles — AGU PUNT SL · Class II
- AGUPUNT APS — AGU PUNT SL · Class II
- AGUPUNT IPEN — AGU PUNT SL · Class II
- AGUPUNT APS — AGU PUNT SL · Class II
Cleared under the same submission
K003748 also covers:
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
- AGUPUNT APS — AGU PUNT SL
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Agu Punt Sl
Sources (1)
- FDA UDI 5be4b452-bb94-45e9-a4db-f36d50f008cb 33 fields · synced May 30, 2026