DEVICE: Medichoice (10885632134548)
Device Identifier (DI) Information
Medichoice
PG4-1563
In Commercial Distribution
OWENS & MINOR DISTRIBUTION, INC.
PG4-1563
In Commercial Distribution
OWENS & MINOR DISTRIBUTION, INC.
Mask Primagard160 Procedure Face Anti-fog Foam Anti Glare Strip Stretchy Earloop W/ Visor Foam Strip Aluminum Nose Piece Not Made With Natural Rubber Latex Indigo Disposable MediChoice
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
58376 | Eye splash shield, single-use |
A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.
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Active | false |
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 in cool, dry, and well ventilated space out of direct sunlight |
Special Storage Condition, Specify: |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f824ff6e-7a47-4c01-8bdc-54f4397b50fb
July 07, 2020
5
August 20, 2016
July 07, 2020
5
August 20, 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 |
---|---|---|---|---|---|
50885632134546 | 4 | 10885632134548 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
60885632134543
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined