AccessGUDID - DEVICE: Face Guard Mirror (05060624125638)

GUDID

Device Identifier (DI) Information

Brand Name: Face Guard Mirror
Version or Model: 925.FGM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 925.FGM
Company Name: CARE SURGICAL LIMITED

Primary DI Number: 05060624125638
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 221313015 *Terms of Use

Device Description: Mirror for use in the prone position. The cogs fitted to the mirror adjust the height or angle of the Face Guard Helmet to achieve the safest natural neutral neckline.

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:	No
Prescription Use (Rx):	No
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?
61129	Patient positioner base plate	A device in the form of a non-mirrored flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices (not included) can be attached [e.g., arch frame, thermoplastic mask, headrest, head positioner]. It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCX	Support, Patient Position

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: No
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: 047a0a80-cd15-493b-9c86-581de8426dad
Public Version Date: March 18, 2025
Public Version Number: 2
DI Record Publish Date: July 22, 2024