PMA P010059S012

Device
MORCHER® EYEJET® CTR Single-Use Injector
Applicant
Morcher GmbH
PMA number
P010059
Supplement
S012
Product code
MRJ
Decision date
2024-03-01
Classification
Ophthalmic
Generic name
Ring, endocapsular
Approval order statement
a change to the ink used for printing on the outside of the Tyvek packaging lid

Current openFDA PMA Record#

Device
MORCHER® EYEJET® CTR Single-Use Injector
Applicant
Morcher GmbH
PMA number
P010059
Supplement
S012
Product code
MRJ
Generic name
Ring, endocapsular
Decision date
2024-03-01
Decision code
OK30
Date received
2024-02-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change to the ink used for printing on the outside of the Tyvek packaging lid