DEVICE: Henry Schein (00304040019313)
Device Identifier (DI) Information
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 |
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Special Storage Condition, Specify: Store at cool dry place. Avoid excessive heat 40C or 104F |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4291e4f5-5fef-4ecc-be56-5f90a9eb2fec
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 |
---|---|---|---|---|---|
10304040019310 | 10 | 00304040019313 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
20304040019317
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined