Coseal Surgical Sealant

Basic Information

• Brand Name: Coseal Surgical Sealant
• Primary DI: 05413765404634
• Version / Model: 934072
• Catalog Number: 934072
• Company Name: BAXTER HEALTHCARE CORPORATION
• Labeler DUNS: 628013963
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-05
• Public Version: 4
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: 2fe42210-6513-4cd2-bcf1-4302da009523

Device Description

Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBE	Sealant,Polymerizing	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58777	Surgical internal adhesive/sealant, synthetic polymer	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05413765404634	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	8	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature (approximately 25 degrees celsius)
• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius