AccessGUDID - DEVICE: Montgomery® Tracheal Fenestrator (EBES3410080)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Tracheal Fenestrator
Version or Model: 341008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 341008
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES3410080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 8

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
33906	Tracheotome	A knife-like, hand-held manual surgical instrument designed to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZT	Cutter, Surgical

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
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size: 8
Outer Diameter: 10 Millimeter

Device Record Status

Public Device Record Key: ed7ca294-7bd7-45d5-bc7a-fa63f8c47e7b
Public Version Date: August 30, 2022
Public Version Number: 3
DI Record Publish Date: September 20, 2015