HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML
AESCULAP - 1050071

A biodegradable synthetic polymer material [e.g., cyanoacrylate, poly glycerol sebacate arylate (PGSA)] intended to be used for internal surgical applications to bond a wide range of tissue types (e.g., bowel, liver, lung, vascular, urological) and might in addition be intended to achieve haemostasis through tissue sealing. It is applied using a disposable applicator (which may be included), and is intended to be fast-setting (self- or light-induced) to form a thin elastic film. After application, this device cannot be reused.

• Volume : 0.500 ML
• Raw material : n-butyl-2-cyanoacrylate

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MPN

Device Name: Tissue Adhesive For The Topical Approximation Of Skin

Device Class: 2

Physical State: N/A

Definition: Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4010

Third Party Flag: N

Medical Specialty: SU

Device Id: 04046963656720

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04046963835682

Package Quantity: 50

Package Discontinue Date: 1/16/2025 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Carton

Device Id: 04046963835682

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 04046963656713

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A