DEVICE: Surgi-Sign (G047SMS11)
Device Identifier (DI) Information
Surgi-Sign
1
In Commercial Distribution
SMS-1
Or-6, LLC
1
In Commercial Distribution
SMS-1
Or-6, LLC
A temporary tattoo that helps healthcare providers mark and confirm the correct operative site before the procedure starts. For more information please visit www.surgisigncom
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
61577 | Skin marking sticker |
A hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FZZ | Marker, Skin |
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
f2b27ddc-1555-4740-9f91-fa98e1d3b23b
March 08, 2021
1
February 27, 2021
March 08, 2021
1
February 27, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
G047SMS10
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined