AccessGUDID - DEVICE: ZeroWire G2 (00818089022314)

GUDID

Device Identifier (DI) Information

Brand Name: ZeroWire G2
Version or Model: 90T3021
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nds Surgical Imaging LLC

Primary DI Number: 00818089022314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081712583 *Terms of Use

Device Description: ZEROWIRE G2 TX, WITH ACCESSORIES FOR RADIANCE 24", 26" AND ENDOVUE 24", WT-P42-13

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:	Yes
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?
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
GCJ	Laparoscope, General & Plastic Surgery

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: d3eee0cb-d00d-4556-b05b-b7b7c9ddaac6
Public Version Date: August 10, 2022
Public Version Number: 1
DI Record Publish Date: August 02, 2022