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Custom AnchorMarker - Gold Marker preloaded in PSS1820SLS Round Hub Needle
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Custom AnchorMarker - Gold Marker preloaded in PSS1820SLS Round Hub Needle FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Model / Reference
- PSS1820SLS Round Hub Needle FDA UDI
Identifiers
- Catalog Number
- CAM0845SLS-1 FDA UDI
- Primary DI / UDI-DI
- 00815165020394 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5650 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological image marker, implantable
Custom AnchorMarker - Gold Marker preloaded in PSS1820SLS Round Hub Needle by Eckert & Ziegler BEBIG GmbH — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Radiological image marker, implantable.
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- X-Mark Ultra — IZI MEDICAL PRODUCTS LLC · Class II
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
- Eckert & Ziegler BEBIG GmbH
Sources (1)
- FDA UDI bb45b856-8caf-4d1e-b92a-ec9a5156fdd5 34 fields · synced May 31, 2026