AccessGUDID - DEVICE: Endure (B531ES1050)

GUDID

Device Identifier (DI) Information

Brand Name: Endure
Version or Model: ES1051217
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ES105
Company Name: ENDURE INDUSTRIES

Primary DI Number: B531ES1050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066087031 *Terms of Use

Device Description: Endotracheal Stylet, size= 10Fr, fits endotracheal tubes of sizes internal diameter 4-5 mm.

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":	Yes
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?
37469	Artificial airway stylet, single-use	A long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSR	Stylet, Tracheal Tube

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 49 Degrees Celsius
Handling Environment Temperature: between 0 and 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: size- 10Fr

Device Record Status

Public Device Record Key: 5124acb8-23aa-4a58-a80e-86f9492d808c
Public Version Date: December 20, 2022
Public Version Number: 3
DI Record Publish Date: February 20, 2018