DEVICE: Up & Up (00794503812368)
Device Identifier (DI) Information
Up & Up
81236
In Commercial Distribution
CIRRUS HEALTHCARE PRODUCTS LLC
81236
In Commercial Distribution
CIRRUS HEALTHCARE PRODUCTS LLC
Cirrus Healthcare Products, 245-09-4315, Flight Earplugs 2 Pair, Nicholas Petry, Npetry@cirrushealthcare.com
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
41230 | Earplugs, reusable |
A device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EWD | Protector, Hearing (Insert) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
88bfec86-b32e-419d-b968-3488223c961e
June 10, 2022
2
March 17, 2021
June 10, 2022
2
March 17, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20794503812362 | 24 | 00794503812368 | 2021-03-11 | Not 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
[?]
631-692-7600
Kmeehan@cirrushealthcare.com
Kmeehan@cirrushealthcare.com