Clear Guide SteriMASK

GUDID B201CGSM1

CLEAR GUIDE MEDICAL, INC.

Intraoperative ultrasound imaging transducer cover
Primary Device IDB201CGSM1
NIH Device Record Key9b09e593-be27-487c-914a-9f314dfe8a80
Commercial Distribution StatusIn Commercial Distribution
Brand NameClear Guide SteriMASK
Version Model NumberCGSM
Company DUNS965399905
Company NameCLEAR GUIDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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
HIBCCB201CGSM0 [Primary]
HIBCCB201CGSM1 [Package]
Contains: B201CGSM0
Package: [20 Units]
In Commercial Distribution

FDA Product Code

KKXDrape, Surgical
PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-23
Device Publish Date2016-09-21

On-Brand Devices [Clear Guide SteriMASK]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.