DEVICE: microMend (00850018777223)
Device Identifier (DI) Information
microMend
M2SXD002
In Commercial Distribution
M2SXD002
Kitotech Medical Inc
M2SXD002
In Commercial Distribution
M2SXD002
Kitotech Medical Inc
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)
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GDT | Staple, Removable (Skin) |
KGX | Tape And Bandage, Adhesive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 16 and 26 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
180d2f0d-b6fd-474a-b4b0-95a19193b3aa
May 17, 2024
2
December 08, 2022
May 17, 2024
2
December 08, 2022
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 |
---|---|
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
[?]
(877) 420-1502
customerservice@kitotechmedical.com
customerservice@kitotechmedical.com