Kronner Low Profile Scope Holder Gas Line Set

Basic Information

• Brand Name: Kronner Low Profile Scope Holder Gas Line Set
• Primary DI: 00856589007011
• Version / Model: 1
• Company Name: KRONNER PROTOTYPES, INCORPORATED
• Labeler DUNS: 091301184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9788111d-06fb-4c03-a3a5-4293a0ba6bae

Device Description

Two flexible gas lines, that are able to withstand up to 150 PSI. Used for the Kronner Low Profile Scope Holder. Sterilized for single-use.

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: No
• 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856589007011	GS1
Package	00856589007066	GS1		25	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K000663	000