DEVICE: Montgomery® Safe-T-Tube™ (EBES4200100)
Device Identifier (DI) Information
Montgomery® Safe-T-Tube™
420010
In Commercial Distribution
420010
Boston Medical Products, Inc.
420010
In Commercial Distribution
420010
Boston Medical Products, Inc.
Size: Standard 10 mm; Type: Clear
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 [?] |
---|---|
K843936 | 000 |
Sterilization
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): 39 mm |
Device Size Text, specify: Outer Diameter (Outer Limb): 8 mm |
Device Size Text, specify: Length (Lower Inner Limb): 23 mm |
Device Size Text, specify: Length (Upper Inner Limb): 19 mm |
Device Size Text, specify: Length (Inner Limb): 50 mm |
Device Size Text, specify: Outer Diameter (Inner Limb): 10 mm |
Device Record Status
49a67205-df16-4ab0-a724-7a2896807ad9
August 30, 2022
4
September 20, 2015
August 30, 2022
4
September 20, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EBES4200101 | 1 | EBES4200100 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-433-2674
info@bosmed.com
info@bosmed.com