AccessGUDID - DEVICE: SOS Malleable Stylet, Green Line (Adult) (B06730000GL0)

GUDID

Device Identifier (DI) Information

Brand Name: SOS Malleable Stylet, Green Line (Adult)
Version or Model: 30000-GL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30000-GL
Company Name: CLARUS MEDICAL, LLC

Primary DI Number: B06730000GL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010316284 *Terms of Use

Device Description: SOS Malleable Stylet, Green Line (Adult)

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):	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?
36706	Flexible intubation laryngoscope, fibreoptic	An endoscope with a flexible inserted portion intended for the visual examination of the upper airway and to assist the entry and positioning of a special airway tube [a long thin version of an endotracheal (ET) tube] to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is very long and thin to facilitate entry and the intubation procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOB	Nasopharyngoscope (Flexible Or Rigid)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant

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: 660b7450-c629-4df8-8dc2-e49b827d37d6
Public Version Date: March 06, 2025
Public Version Number: 3
DI Record Publish Date: September 20, 2016