DEVICE: Monoart (E307220103800)
Device Identifier (DI) Information
Monoart
MONOART APRON PG30
In Commercial Distribution
22010380
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution
22010380
EURONDA SPA
Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene.
Size 610 x 530 mm.
Carton of 6 rolls.
Colour: emerald green
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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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? |
---|---|---|---|---|
61048 | Patient examination/treatment drape, single-use |
A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KHR | Absorber, Saliva, Paper |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ecc55e08-7d4b-4c0a-ac5f-dd969a2d505f
December 24, 2019
1
December 16, 2019
December 24, 2019
1
December 16, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
E307220103801 | 6 | E307220103802 | In Commercial Distribution | Carton | |
E307220103802 | 80 | E307220103800 | In Commercial Distribution | Aprons |
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
[?]
No Customer Contact currently defined