HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML
AESCULAP - 1050071
Device Description
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.
Environmental Conditions
- 22.00
- N/A
Device Sizes
- Volume : 0.500 ML
- Raw material : n-butyl-2-cyanoacrylate
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 04046963656720
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04046963835682
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: 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