DEVICE: Essentials (00304040019245)
Device Identifier (DI) Information
Essentials
1126761
In Commercial Distribution
1126761
HENRY SCHEIN, INC.
1126761
In Commercial Distribution
1126761
HENRY SCHEIN, INC.
Essentials EL Procedure Masks
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Surgical face mask, single-use | A device intended to be placed over the nose and mouth of medical personnel to prevent the transmission of airborne organisms during surgery or patient examination. It is made of a flexible porous fabric material that allows the user to breath normally through the mask and typically includes a metal wire along one border to form fit the nose bridge; it is typically held in place with ties that fasten at the back of the user's head. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FXX | Mask, surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store at cool dry place. Avoid excessive heat 40C or 104F |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
b326a7aa-5474-40d7-8e36-9a79c76191ed
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10304040019242 | 20 | 00304040019245 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
20304040019249
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined