microMend PRO MM12XS2

GUDID 00850018777049

Skin Closure Devices: Small - 7 mm x 28 mm (2 Closures per Pouch)

Kitotech Medical Inc

Skin-closure adhesive strip
Primary Device ID00850018777049
NIH Device Record Key84230eeb-ebac-4bf2-a8eb-10c1603a0feb
Commercial Distribution StatusIn Commercial Distribution
Brand NamemicroMend PRO
Version Model NumberMM12XS2
Catalog NumberMM12XS2
Company DUNS007908602
Company NameKitotech Medical Inc
Device Count24
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com
Phone(877) 420-1502
Emailcustomerservice@kitotechmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018777049 [Primary]
GS100850018777216 [Unit of Use]

FDA Product Code

GDTStaple, Removable (Skin)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-05-17
Device Publish Date2022-12-08

On-Brand Devices [microMend PRO]

00850018777179Skin Closure Devices: Wide with Aperture: 38mm x 28 mm (2 Closures per Pouch)
00850018777155Skin Closure Devices: Wide without Aperture: 38mm x 28 mm (2 Closures per Pouch)
00850018777094Skin Closure Devices: Large - 12 mm x 43 mm (2 Closures per Pouch)
00850018777216Skin Closure Devices: Small - 7 mm x 28 mm (2 Closures per Pouch)
00850018777001Skin Closure Devices: Medium - 12 mm x 28 mm (2 Closures per Pouch)
00850018777292Skin Closure Devices: Umbilical - 12 mm x 26 mm (2 Closures per Pouch)
00850018777278Skin Closure Devices: Large - 12 mm x 43 mm (4 Closures per Pouch)
00850018777117Skin Closure Devices: Medium - 12 mm x 28 mm (4 Closures per Pouch)
00850018777049Skin Closure Devices: Small - 7 mm x 28 mm (2 Closures per Pouch)

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