AccessGUDID - DEVICE: IDENTIFY (EHUQHQ0100707)

GUDID

Device Identifier (DI) Information

Brand Name: IDENTIFY
Version or Model: 1.7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HQ01007
Company Name: humediQ global GmbH

Primary DI Number: EHUQHQ0100707
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314128217 *Terms of Use

Device Description: The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
60473	Radio-frequency identification patient positioning/tracking system application software	An application software program intended to be used with a radio-frequency identification patient positioning/tracking system. It is typically installed on an off-the-shelf computer and is used to integrate the components of the system, e.g., radio-frequency identification (RFID) tags and readers, optical/infrared cameras, and a hand-held control unit. It typically includes upgrades to the software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112692	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: 05bea44b-7a91-47fa-a6f1-d2497afee1dc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 20, 2016