Face Guard Set (Helmet + Mirror) 925.FGS

GUDID 05060624125614

Helmet and mirror for use in the prone position. The helmet holds the Face Guard Cushion to maintain their integrity throughout prone procedures.

CARE SURGICAL LIMITED

Patient positioner base plate
Primary Device ID05060624125614
NIH Device Record Key283054e9-8d4e-45e0-a999-68a309bc4a31
Commercial Distribution StatusIn Commercial Distribution
Brand NameFace Guard Set (Helmet + Mirror)
Version Model Number925.FGS
Catalog Number925.FGS
Company DUNS221313015
Company NameCARE SURGICAL LIMITED
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060624125614 [Primary]

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-30
Device Publish Date2024-07-22

Devices Manufactured by CARE SURGICAL LIMITED

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05060624126710 - CS Jackson Covers Hip & Thigh Combo Set2024-11-06
05060624120862 - CS Jackson Chest Cushion with Hip/Thigh Combo Covers2024-11-06
05060624120503 - CS Comfort Chest Cushion (60mm)2024-11-06
05060624120510 - CS Comfort Hip and Thigh Cushions (60mm)2024-11-06
05060624120527 - CS Comfort Arm Cushions (Pair)2024-11-06
05060624120541 - CS Comfort Leg Cushion2024-11-06

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