DEVICE: SagiPlan® V.2.x Prostate Module Add-on SW (04049223106751)

Device Identifier (DI) Information

SagiPlan® V.2.x Prostate Module Add-on SW
1374-0610#01
In Commercial Distribution
1374-0600
Eckert & Ziegler BEBIG GmbH
04049223106751
GS1

1
331080432 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Radiation therapy software An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.
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FDA Product Code

[?]
Product Code Product Code Name
MUJ System,Planning,Radiation Therapy Treatment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141900 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

0b4ad03b-5848-4f18-927d-2ee63cf533c2
July 06, 2018
3
November 10, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+4930941084130
info@bebig.com
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