AccessGUDID - DEVICE: iCAP Imaging Cap (00893872001028)

GUDID

Device Identifier (DI) Information

Brand Name: iCAP Imaging Cap
Version or Model: IC-100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 200549
Company Name: Nova Eye, Inc.

Primary DI Number: 00893872001028
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 079755637 *Terms of Use

Device Description: Imaging Cap

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?
43970	Cable/lead/sensor/probe cover, sterile	A sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
ITX	Transducer, Ultrasonic, Diagnostic

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: Yes
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: aac518e9-bf29-4a60-bef4-27c2721d9fc8
Public Version Date: December 08, 2020
Public Version Number: 4
DI Record Publish Date: September 19, 2016