DEVICE: Surgi-Sign (G047SMSRKT1)

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Device Record History
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Device Identifier (DI) Information
Surgi-Sign
1
In Commercial Distribution
SMS-RKT
Or-6, LLC
G047SMSRKT1
HIBCC

50
033826164 *Terms of Use
A temporary tattoo that helps healthcare providers mark and confirm the correct operative site before the procedure. For more information please visit www.surgisign.com
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FZZ Marker, Skin
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b6769e0b-3c3e-43cd-ba32-6fdb6e9843f5
March 08, 2021
1
February 27, 2021
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: G047SMSRKT0 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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