microMend PRO MM12LG4

GUDID 00850018777278

Skin Closure Devices: Large - 12 mm x 43 mm (4 Closures per Pouch)

Kitotech Medical Inc

Skin-closure adhesive strip

• Primary Device ID: 00850018777278
• NIH Device Record Key: c6895683-366f-41ac-9033-0c819d160291
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microMend PRO
• Version Model Number: MM12LG4
• Catalog Number: MM12LG4
• Company DUNS: 007908602
• Company Name: Kitotech Medical Inc
• Device Count: 48
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com
• Phone: (877) 420-1502
• Email: customerservice@kitotechmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018777278 [Unit of Use]
GS1	00850018777285 [Primary]

FDA Product Code

• GDT: Staple, Removable (Skin)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-05-17
• Device Publish Date: 2022-12-08

On-Brand Devices [microMend PRO]

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