Identity
- Trade Name
- AutoMark FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- CS 10-SEMIAUTOM, NOT REPOSITIONABLE NEEDLE 20G X 50mm FOR MAMMARY NODULE LOCALIZATION, DOUBLE HOOK FDA UDI
- Model / Reference
- PNAX2005 FDA UDI
- Description
- CS 10-SEMIAUTOM, NOT REPOSITIONABLE NEEDLE 20G X 50mm FOR MAMMARY NODULE LOCALIZATION, DOUBLE HOOK FDA UDI
Identifiers
- Catalog Number
- PNAX2005 FDA UDI
- Primary DI / UDI-DI
- 08032986359447 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
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 20 Gauge FDA UDILength — 50 Millimeter FDA UDI
AutoMark by M.d.l. S.r.l. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 d537102c-adc0-4a99-b617-5bda787dde15 36 fields · synced May 30, 2026