Simpulse

Basic Information

• Brand Name: Simpulse
• Primary DI: 00801741010330
• Version / Model: 0037630
• Catalog Number: 0037630
• Company Name: Davol Inc.
• Labeler DUNS: 001191048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-23
• Public Version: 3
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: 096432fb-77f0-48c2-9e55-fca958eb684f

Device Description

Simpulse Suction Irrigator Splash Shield

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
FQH	LAVAGE, JET	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63247	Surgical instrument guard, single-use	A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10801741010337	GS1	CA	10	In Commercial Distribution
Primary	00801741010330	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	4	Inch