DEVICE: Aligned Medical Solutions (B098AMS14557A0)
Device Identifier (DI) Information
Aligned Medical Solutions
AMS14557A
In Commercial Distribution
AMS14557A
Aligned Medical Solutions
AMS14557A
In Commercial Distribution
AMS14557A
Aligned Medical Solutions
LASIK PACK
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
45150 | Ophthalmic surgical procedure kit, non-medicated, single-use |
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OJK | Eye Tray |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
51fe8c22-bb0c-40d9-b864-7e8f54e1b92b
January 05, 2024
1
December 28, 2023
January 05, 2024
1
December 28, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B098AMS14557A1 | 20 | B098AMS14557A0 | In Commercial Distribution | CASE |
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
[?]
18006377056
CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM
CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM