AccessGUDID - DEVICE: Radlink GPS Tablet 2200 (00866389000112)

GUDID

Device Identifier (DI) Information

Brand Name: Radlink GPS Tablet 2200
Version or Model: TABLET
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RADLINK, INC.

Primary DI Number: 00866389000112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069190036 *Terms of Use

Device Description: The Radlink GPS Tablet provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS Tablet and its Surgeon’s Checklist software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS Tablet consists of a Tablet PC computer system that uses a touchscreen monitor & other image display accessories. Pre-operative images can be viewed on the GPS Tablet during surgery, which surgeons can use to reference against the intraoperative images captured during the procedure. For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture intraoperative images, which takes approximately four seconds to appear on the GPS Tablet. For anterior approach THA procedures, C-Arm images are instantaneously transferred to the GPS Tablet using the Radlink Wireless C-Arm Kit.

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?
17175	Radiology information system	A dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)

FDA Premarket Submission

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

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: 5a7e67cb-65e1-403b-a87a-c423a8fa6a2e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016