Clear Guide SteriMASK CG-SM-M

GUDID B201CGSMM0

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.

CLEAR GUIDE MEDICAL, INC.

Optical medical device procedural cover
Primary Device IDB201CGSMM0
NIH Device Record Key33153273-0df7-402e-b320-5cfb1b2f138a
Commercial Distribution StatusIn Commercial Distribution
Brand NameClear Guide SteriMASK
Version Model NumberCGSMM
Catalog NumberCG-SM-M
Company DUNS965399905
Company NameCLEAR GUIDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com
Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com
Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com
Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com
Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com
Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com
Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com
Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com
Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com
Phone+1 (443) 267-7661
Emailsupport@clearguidemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB201CGSMM0 [Primary]
HIBCCB201CGSMM1 [Package]
Package: Box [20 Units]
In Commercial Distribution
HIBCCB201CGSMM2 [Package]
Package: Case [50 Units]
In Commercial Distribution

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-11
Device Publish Date2022-10-03

On-Brand Devices [Clear Guide SteriMASK]

B201CGSM1CGSM
B201CGSMM0The device is a sterile accessory intended to provide a sterile barrier for medical procedures t

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