AMT Stiffener for Initial Placement

Basic Information

• Brand Name: AMT Stiffener for Initial Placement
• Primary DI: 00842071130619
• Version / Model: E4-6010
• Catalog Number: E4-6010, 4-6010
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 038101861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-14
• Public Version: 2
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 232b4737-c26b-4e14-ba3d-aff4433ba819

Device Description

Guidewire Compatible Stiffener for Initial Placement, 10F Compatible (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
13837	Peritoneal catheter stylet	A thin wire/rod intended to be inserted within the lumen of a peritoneal catheter (e.g., peritoneal dialysis catheter, peritoneal drainage catheter, peritoneal lavage catheter, abdominal fluid shunt system peritoneal catheter) to stiffen/maintain the shape of the catheter to assist introduction; it may also be intended to assist insertion of a bladder catheter used for drainage of fluid from the peritoneal cavity to the bladder. It is intended to be removed once the catheter is in place. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00842071130626	GS1	Box (4-6010)	10	In Commercial Distribution
Primary	00842071130619	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042300	000