640

Basic Information

• Brand Name: 640
• Primary DI: 03596010492067
• Version / Model: 7210236
• Catalog Number: 7210236
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-30
• Public Version: 3
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 3585b0eb-db65-41e9-bcc3-8a9fb802e300
• Distribution End Date: 2017-04-03

Device Description

KIT IMS 640 INTL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Manufacturing Date: No
• 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
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35616	Endoscopic video imaging system	An assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with light cables, video recorder, imaging units with perhaps a colour compensation device, a distention unit, and a visual display unit (VDU), all of which is typically placed/mounted onto a trolley (cart) that can be moved to different examination/treatment rooms.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03596010492067	GS1

Customer Contacts

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