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GammaPod™ Breast Immobilization and Localization System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- GammaPod™ Breast Immobilization and Localization System FDA UDI
- Generic Name
- Stereotactic radiotherapy breast positioning system outer cup FDA UDI
- Device Name
- Medium FDA UDI
- Model / Reference
- Outer Breast Cup FDA UDI
- Description
- Medium FDA UDI
Identifiers
- Catalog Number
- XMSGP030A10.00-0.05 FDA UDI
- Primary DI / UDI-DI
- 00850002615067 FDA UDI
- FDA Product Code
- IWB FDA UDI
- GMDN Term
- Stereotactic radiotherapy breast positioning system outer cup FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stereotactic radiotherapy breast positioning system outer cup
GammaPod™ Breast Immobilization and Localization System by Xcision Medical Systems, LLC — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Stereotactic radiotherapy breast positioning system outer cup.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Xcision Medical Systems, LLC
Sources (1)
- FDA UDI af882a4c-3ad6-4c68-a604-71f9b7b282fe 35 fields · synced Jun 8, 2026