DEVICE: Bivalve Nasal Splint, Standard (EBES603010)
Device Identifier (DI) Information
Bivalve Nasal Splint, Standard
60-301
In Commercial Distribution
60-301
Boston Medical Products, Inc.
60-301
In Commercial Distribution
60-301
Boston Medical Products, Inc.
Size: 0.25 x 27 x 42 mm
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
31919 | Intranasal splint, non-biodegradable |
A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LYA | Splint, Intranasal Septal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K972096 | 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 |
---|
Width: 0.25 Millimeter |
Length: 27 Millimeter |
Height: 42 Millimeter |
Device Record Status
58865af9-bc65-490c-82cb-2a2b88626d9c
August 30, 2022
6
September 20, 2015
August 30, 2022
6
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 |
---|---|---|---|---|---|
EBES603011 | 5 | EBES603010 | 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