EndoRotor® Filter Set

Basic Information

• Brand Name: EndoRotor® Filter Set
• Primary DI: 00865830000251
• Version / Model: ER 40-01
• Catalog Number: ER 40-01
• Company Name: INTERSCOPE, INC
• Labeler DUNS: 968227913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-02
• Public Version: 1
• Public Version Date: 2019-08-12
• Public Version Status: New
• Public Device Record Key: d18d5190-9125-4853-a85d-fd8684fe776c

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PTE	Endoscopic Morcellator Gastroenterology	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62064	Suction system filter, tissue, non-sterile	A non-sterile device intended to be fitted into a suction system bottle/canister to separate tissue from the aspirate during a surgical procedure; the tissue may be subsequently used for various diagnostic purposes (e.g., histological analysis). It consists of a meshed piece of textile material (e.g., nylon). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00865830000251	GS1

Customer Contacts

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