Grip-Lok

Basic Information

• Brand Name: Grip-Lok
• Primary DI: 00618125134892
• Version / Model: 3600PFC
• Catalog Number: 3600PFC
• Company Name: TIDI PRODUCTS, LLC
• Labeler DUNS: 063519193
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-13
• Public Version: 1
• Public Version Date: 2022-10-21
• Public Version Status: New
• Public Device Record Key: abb7f78d-d6b9-4297-a655-a8e7f19eaac2

Device Description

Small Foley Catheter Securement Device, For 2 & 3 Way Foley Catheters Sized 8-30 Fr

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	876.5130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59782	Retinitis pigmentosa IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose, monitor or predict the inherited genetic condition retinitis pigmentosa, a group of inherited ocular diseases that result in progressive retinal degeneration which may occur as non-syndromic or syndromic (Usher syndrome, Bardet-Biedl syndrome, Refsum disease) mutations.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10618125134899	GS1	Box	100	In Commercial Distribution
Primary	00618125134892	GS1
Package	20618125134896	GS1	Box	1000	In Commercial Distribution