AccessGUDID - DEVICE: Iplan Rt Dose, Iplan Rt Adaptive, Iplan Rt Phantom Qa, Iplan Rt Review (04056481138608)

GUDID

Device Identifier (DI) Information

Brand Name: Iplan Rt Dose, Iplan Rt Adaptive, Iplan Rt Phantom Qa, Iplan Rt Review
Version or Model: 4.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21381E
Company Name: Brainlab SE

Primary DI Number: 04056481138608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314482980 *Terms of Use
Previous DI: 04056481000592

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40887	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUJ	System,Planning,Radiation Therapy Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080888	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 681353a0-6992-4cee-aa1d-2f93c79681c9
Public Version Date: September 17, 2025
Public Version Number: 5
DI Record Publish Date: June 14, 2017