AccessGUDID - DEVICE: Clear Guide SteriMASK (B201CGSMM0)

GUDID

Device Identifier (DI) Information

Brand Name: Clear Guide SteriMASK
Version or Model: CGSMM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CG-SM-M
Company Name: CLEAR GUIDE MEDICAL, INC.

Primary DI Number: B201CGSMM0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965399905 *Terms of Use

Device Description: The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
44711	Optical medical device procedural cover	A device designed to fit over the distal end of a non-surgically-invasive device with optical functionality (e.g., laser beam-guide, optical scanning handpiece, endoscope) during use, to act as a cover/shield to avoid direct contact to the eye and/or cross-contamination between patients; it is not intended to act as a spacer. It is typically a small rigid partially- or fully- transparent plastic device. This is a single-use device.	Active	false
44714	Intraoperative ultrasound imaging transducer cover	A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUI	Drape, Surgical, Exempt

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: 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: 33153273-0df7-402e-b320-5cfb1b2f138a
Public Version Date: October 11, 2022
Public Version Number: 1
DI Record Publish Date: October 03, 2022