AccessGUDID - DEVICE: PROACT MR Conditional (25060179635181)

GUDID

Device Identifier (DI) Information

Brand Name: PROACT MR Conditional
Version or Model: MRHPCMAC2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MRHPCMAC2
Company Name: PROACT MEDICAL LIMITED

Primary DI Number: 25060179635181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 491090502 *Terms of Use

Device Description: MR Conditional HPC Green System Laryngoscope Blade, MAC 2

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	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?
46828	Laryngoscope blade, single-use	The segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCW	Laryngoscope, Rigid

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
Device Size Text, specify: MAC 2

Device Record Status

Public Device Record Key: 3bfc19a2-b18d-416c-acbb-24f350423c28
Public Version Date: August 23, 2023
Public Version Number: 1
DI Record Publish Date: August 15, 2023