Tissue Seal

Basic Information

• Brand Name: Tissue Seal
• Primary DI: 00860000589031
• Version / Model: 1051260-P
• Company Name: TISSUE SEAL L.L.C.
• Labeler DUNS: 805666588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-01
• Public Version: 1
• Public Version Date: 2019-12-09
• Public Version Status: New
• Public Device Record Key: ae27e61c-c7f6-4530-82d0-ffb4c209a147

Device Description

Topical Skin Adhesive Flex with Tips

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
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	878.4010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58779	Dermal surgical adhesive/sealant applicator	A sterile applicator designed to distribute surgical adhesive/sealant for topical application to the skin for various haemostatic and/or tissue bonding uses during a surgical procedure, or as treatment for traumatic or atraumatic cutaneous wounds. It typically consists of a small plastic spout with a brush tip that is attached to a vial of adhesive which is manually squeezed. This is a single-use device.	No	Active
34164	Skin-approximation adhesive	A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860000589038	GS1	Box	10	In Commercial Distribution
Primary	00860000589031	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140343	000

Device Sizes

Type	Value	Unit	Text
Total Volume	0.5	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius