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GammaPod™ Breast Immobilization and Localization System

FDA UDI

Class II (US FDA UDI)

by Xcision Medical Systems, LLC

Identity

Trade Name
GammaPod™ Breast Immobilization and Localization System FDA UDI
Generic Name
Stereotactic radiotherapy breast positioning system inner cup FDA UDI
Device Name
M08 FDA UDI
Model / Reference
Inner Breast Cup FDA UDI
Description
M08 FDA UDI

Identifiers

Catalog Number
XMSGP030A10.02-019 FDA UDI
Primary DI / UDI-DI
10850002615293 FDA UDI
FDA Product Code
IWB FDA UDI
GMDN Term
Stereotactic radiotherapy breast positioning system inner 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 790 Milliliter FDA UDI

Category: Stereotactic radiotherapy breast positioning system inner 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 inner cup.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xcision Medical Systems, LLC

Sources (1)

  • FDA UDI 1e88efd0-6ce2-4537-8a54-976860304f6d 36 fields · synced Jun 8, 2026