AccessGUDID - DEVICE: Hebeler Safe-T-Tube™ (EBES4500150)

GUDID

Device Identifier (DI) Information

Brand Name: Hebeler Safe-T-Tube™
Version or Model: 450015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 450015
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES4500150
Issuing Agency: HIBCC
Commercial Distribution End Date: April 15, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 15 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?
35458	Trachea prosthesis	An implantable artificial substitute for the natural trachea used in airway reconstructive surgery. It is typically a semi-rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal trachea prosthesis may be uncovered or covered with a polymeric material.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
BTR	Tube, Tracheal (W/Wo Connector)

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length (Outer Limb): 59 mm
Device Size Text, specify: Outer Diameter (Outer Limb): 12 mm
Device Size Text, specify: Length (Lower Inner Limb): 40 mm
Device Size Text, specify: Length (Upper Inner Limb): 25 mm
Device Size Text, specify: Length (Inner Limb): 77 mm
Device Size Text, specify: Outer Diameter (Inner Limb): 15 mm

Device Record Status

Public Device Record Key: 96e3d7db-37ae-4b37-abde-4da3c94c4d99
Public Version Date: August 30, 2022
Public Version Number: 3
DI Record Publish Date: September 20, 2015