GLUSTITCH TWIST

Basic Information

• Brand Name: GLUSTITCH TWIST
• Primary DI: D7950000130
• Version / Model: GLTWI05
• Company Name: Glustich Inc
• Labeler DUNS: 201637158
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-13
• Public Version: 4
• Public Version Date: 2019-03-01
• Public Version Status: Update
• Public Device Record Key: 2131347b-76d7-478d-b4a4-ae2e4ff619fd
• Distribution End Date: 2019-03-01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
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	D7950000131	HIBCC	BOX	6	Not in Commercial Distribution	2019-03-01
Primary	D7950000130	HIBCC
Package	D7950000132	HIBCC	BOX	12	Not in Commercial Distribution	2019-03-01

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150032	000