Modulap

Basic Information

• Brand Name: Modulap
• Primary DI: 00817428021445
• Version / Model: 4587
• Company Name: ATC TECHNOLOGIES, INC.
• Labeler DUNS: 023131605
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-25
• Public Version: 1
• Public Version Date: 2024-12-03
• Public Version Status: New
• Public Device Record Key: 73faa360-334a-4523-919d-455ed656016b

Device Description

5mmx45cm J-Hook Tip

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: 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64111	Laparoscopic irrigation cannula	A rigid, hand-operated, single-lumen tube intended to be inserted through a laparoscopic port to provide a conduit for irrigation of body cavities/wounds during a laparoscopic procedure, to facilitate observation. It is not designed to administer parenteral fluids or drugs; it is not designed for surgical aspiration (suction). It is connected via tubing to an appropriate irrigating device (not included). It may be provided with a handle with a valve(s) and hole(s) on its side for the control of irrigation, and/or connection tubing; it is typically made of metal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817428021445	GS1

Premarket Submissions

Submission Number	Supplement Number
K983623	000