Identity
- Trade Name
- AutoMark FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- DISPOSABLE SEMI-AUTOMATIC NON REPOSITIONAL NEEDLE 20G x 50 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK FDA UDI
- Model / Reference
- PNA2005 FDA UDI
- Description
- DISPOSABLE SEMI-AUTOMATIC NON REPOSITIONAL NEEDLE 20G x 50 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK FDA UDI
Identifiers
- Catalog Number
- PNA2005 FDA UDI
- Primary DI / UDI-DI
- 08056138586253 FDA UDI
- FDA Product Code
- GDF FDA UDI
- GMDN Term
- Radiological image marker, implantable 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
Yes
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 — 50 Millimeter FDA UDINeedle Gauge — 20 Gauge FDA UDI
Category: Radiological image marker, implantable
AutoMark by M.d.l. S.r.l. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological image marker, implantable.
- UltraClip® Dual Trigger Breast Tissue Marker — Bard Peripheral Vascular · Class II
- SenoMark® UltraCor® Breast Tissue Marker — Bard Peripheral Vascular · Class II
- Breast localisation needle — Möller Medical GmbH · Class I
- Stellar Medical — Stellar Medical, LLC · Class II
- SecurMark for ATEC — Hologic, Inc. · Class II
- HydroMark — Devicor Medical Products, Inc. · Class II
- X-Mark Ultra — IZI MEDICAL PRODUCTS LLC · Class II
- VISICOIL MR — IZI MEDICAL PRODUCTS LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- M.d.l. S.r.l.
Sources (2)
- FDA UDI 01c82a70-eb51-4e0c-b3bc-c72709c29bb5 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026