AccessGUDID - DEVICE: GlideScope® (00879123009272)

GUDID

Device Identifier (DI) Information

Brand Name: GlideScope®
Version or Model: Spectrum QC eco Hyperangle S2.5, Non-Sterile
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0574-0266
Company Name: Verathon Medical (Canada) ULC

Primary DI Number: 00879123009272
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243738320 *Terms of Use

Device Description: GlideScope® Spectrum QC eco Hyperangle S2.5, Non-Sterile

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:	Yes
Prescription Use (Rx):	Yes
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?
62760	Video intubation laryngoscope blade	A rigid, blade-like component of a bladed video intubation laryngoscope 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 has an electronic camera at its distal end to transmit anatomical images by a video system to a connected video intubation laryngoscope handle/monitor. 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
No Device Sizes

Device Record Status

Public Device Record Key: ac8f67a5-4b14-425f-92d9-3fb32d990558
Public Version Date: October 24, 2024
Public Version Number: 1
DI Record Publish Date: October 16, 2024