AccessGUDID - DEVICE: TP-LINK (00817613020215)

GUDID

Device Identifier (DI) Information

Brand Name: TP-LINK
Version or Model: Wifi-Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Nds Surgical Imaging LLC

Primary DI Number: 00817613020215
Issuing Agency: GS1
Commercial Distribution End Date: February 23, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 081712583 *Terms of Use

Device Description: TP-LINK router and cables

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:	Yes
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?
32547	Medical networking interface unit	An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 98a85784-6664-49a2-ad37-164cf727be5d
Public Version Date: November 27, 2024
Public Version Number: 6
DI Record Publish Date: February 23, 2018