DEVICE: microMend (00850018777223)

Device Identifier (DI) Information

microMend
M2SXD002
In Commercial Distribution
M2SXD002
Kitotech Medical Inc
00850018777223
GS1

1
007908602 *Terms of Use
Emergency Laceration Closures (Qty. 4), COMBO: 1 Pack of 2 SMALL 1/4 IN x 1 IN (7 mm x 28 mm); 1 Pack of 2 MEDIUM 1/2 IN x 1 IN (12 mm x 28 mm)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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?
32207 Skin-closure adhesive strip
A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GDT Staple, Removable (Skin)
KGX Tape And Bandage, Adhesive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 16 and 26 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

180d2f0d-b6fd-474a-b4b0-95a19193b3aa
May 17, 2024
2
December 08, 2022
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
(877) 420-1502
customerservice@kitotechmedical.com
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