AccessGUDID - DEVICE: Stylet – Tracheal Tube/ Bougie Catheter (00860004198802)

GUDID

Device Identifier (DI) Information

Brand Name: Stylet – Tracheal Tube/ Bougie Catheter
Version or Model: CM001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CM001
Company Name: GMMI SDN. BHD.

Primary DI Number: 00860004198802
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 865757421 *Terms of Use

Device Description: No description.

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?
63633	Tracheostomy tube guidewire	A sterile wire intended to assist manual introduction of a tracheostomy tube guide-catheter used to facilitate the insertion or reinsertion of a tracheostomy tube into the trachea through the skin after a percutaneous tracheotomy. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2cde0e8-0a52-4732-9070-9babe9d12123
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: June 08, 2020