Identity
- Trade Name
- Markslim FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- DISPOSABLE NON-REPOSITIONAL NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, SLIM LINE, SIGNLE HOOK FDA UDI
- Model / Reference
- PNS2015 FDA UDI
- Description
- DISPOSABLE NON-REPOSITIONAL NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, SLIM LINE, SIGNLE HOOK FDA UDI
Identifiers
- Catalog Number
- PNS2015 FDA UDI
- Primary DI / UDI-DI
- 08056138586314 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
- Needle Gauge — 20 Gauge FDA UDILength — 150 Millimeter FDA UDI
Category: Radiological image marker, implantable
Markslim by M.d.l. S.r.l. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- M.d.l. S.r.l.
Sources (2)
- FDA UDI 8c51ebd8-2529-4199-88cd-2c969794282c 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026