AccessGUDID - DEVICE: BATCAM MultiProbe, 230V, Terason 3000 (00852656007076)

GUDID

Device Identifier (DI) Information

Brand Name: BATCAM MultiProbe, 230V, Terason 3000
Version or Model: 209718
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Best Nomos

Primary DI Number: 00852656007076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 146920025 *Terms of Use

Device Description: Parts of the internal anatomy move relative to external or bony landmarks. The BATCAM 7.0 MultiProbe Ultrasound Localization and Positioning System resolves this movement by permitting it’s users to locate and position the part of the internal anatomy that is being treated as accurately and correctly as possible for the delivery of conformal radiation without relying on external structures.

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?
45446	Ultrasound patient positioning system	An assembly of devices used to locate, with ultrasound, internal soft-tissue anatomy that moves relative to external or bony landmarks, to enable subsequent adjustment of the patient for precise external beam radiation treatment of the target tissue. It typically includes an ultrasound imaging system, computerized workstation(s), optical tracking devices, and dedicated software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical
IYO	System, Imaging, Pulsed Echo, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070611	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: be96b812-9cc1-42e1-a6e1-a70d12eeb058
Public Version Date: August 16, 2018
Public Version Number: 4
DI Record Publish Date: October 31, 2016