AccessGUDID - DEVICE: miniPhantom R (EIBAM10900000)

GUDID

Device Identifier (DI) Information

Brand Name: miniPhantom R
Version or Model: M1090000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: IBA Dosimetry GmbH

Primary DI Number: EIBAM10900000
Issuing Agency: HIBCC
Commercial Distribution End Date: April 21, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 332599307 *Terms of Use

Device Description: miniPhantom R used as Patient QA Phantom with MatriXX Resolution

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):	Yes
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?
38399	Accelerator system quality assurance device	An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXG	Phantom, Anthropomorphic, Radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: e34667a6-8b17-4bb7-a8f9-7f28422c434a
Public Version Date: April 21, 2021
Public Version Number: 2
DI Record Publish Date: April 07, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
EIBAM10900001	1	EIBAM10900000	2021-04-21	Not in Commercial Distribution	Carry Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1 786 288 0369
Email: service-usa@iba-group.com

Phone: +861080809288
Email: service-apac@iba-group.com

Phone: +49912860738
Email: service-emea@iba-group.com

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