AMT Stiffener for Initial Placement

Basic Information

• Brand Name: AMT Stiffener for Initial Placement
• Primary DI: 00842071106898
• Version / Model: E4-6000
• Catalog Number: E4-6000, 4-6000
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 038101861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: 701334b8-9745-426a-ab8f-4fd8d7935ac4

Device Description

Guidewire Compatible Stiffener for Initial Placement (Pouched)

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: Yes
• 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
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64462	Gastrostomy procedure kit	A collection of surgical devices, which does not include a gastrostomy tube, intended to assist with a gastrostomy procedure (the surgical creation of a stoma into the stomach for placement of a gastrostomy tube). It typically includes devices dedicated to tube introduction/function (e.g., introduction needle, guidewire, dilator, fastener) with a surgical cutting device(s) intended to be used to perform the gastrostomy (e.g., scalpel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00842071111809	GS1	Box (4-6000)	10	In Commercial Distribution
Primary	00842071106898	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042300	000