The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components.
Coseal Surgical Sealant Extended Applicator - 934034
Device Description
A sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device.
Environmental Conditions
- Store at room temperature (approximately 25 degrees celsius)
Device Sizes
- Length: 22 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NBE
Device Name: Sealant, Polymerizing
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
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: Y
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device Identifiers
Device Id: 00085412083339
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: 50085412083334
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00085412083339
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
