Identity
- Trade Name
- Intro FDA UDI
- Generic Name
- Orthopaedic coaxial injection applicator FDA UDI
- Device Name
- COAXIAL INTRODUCER NEEDLE 15G x 52 mm FDA UDI
- Model / Reference
- PT15052 FDA UDI
- Description
- COAXIAL INTRODUCER NEEDLE 15G x 52 mm FDA UDI
Identifiers
- Catalog Number
- PT15052 FDA UDI
- Primary DI / UDI-DI
- 08056138586499 FDA UDI
- FDA Product Code
- MJG FDA UDI
- GMDN Term
- Orthopaedic coaxial injection applicator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 52 Millimeter FDA UDINeedle Gauge — 15 Gauge FDA UDI
Category: Orthopaedic coaxial injection applicator
Intro by M.d.l. S.r.l. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- M.d.l. S.r.l.
Sources (1)
- FDA UDI bd49e08d-6eba-4b61-ad64-6e04342a5f2e 35 fields · synced Jun 8, 2026