DEVICE: Rutter Stent (EBES8400060)
Device Identifier (DI) Information
Rutter Stent
840006
In Commercial Distribution
840006
Boston Medical Products, Inc.
840006
In Commercial Distribution
840006
Boston Medical Products, Inc.
Size: 6 mm; Type: Radiopaque
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? |
---|---|---|---|---|
42672 | Polymeric laryngeal stent |
A sterile non-bioabsorbable device intended to be implanted in the larynx for the prevention and treatment of laryngeal stenosis and/or chronic aspiration postoperatively. It is typically a hollow, semi-soft moulded device made of a synthetic polymer(s) (e.g., silicone) intended to conform to the endolaryngeal surface. Disposable devices intended to assist implantation may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FWN | Prosthesis, Larynx (Stents And Keels) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K091135 | 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 |
---|
Length: 83 Millimeter |
Outer Diameter: 6 Millimeter |
Device Record Status
d12372d2-c69c-4705-a5eb-f9f5f8f1e14f
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 |
---|---|---|---|---|---|
EBES8400061 | 1 | EBES8400060 | 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