Endocuff

Basic Information

• Brand Name: Endocuff
• Primary DI: 05060423410119
• Version / Model: AEC140
• Company Name: BODDINGTONS PLASTICS LIMITED
• Labeler DUNS: 216745893
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-08
• Public Version: 5
• Public Version Date: 2024-02-21
• Public Version Status: Update
• Public Device Record Key: 966c31e9-e8d4-4a7a-81af-cfb08969d5b8

Device Description

AEC140 Size 4 (Xl) Endocuff Sterile Orange- 1 pot - single unit

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: Yes
• 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
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60911	Colonic endoscopy cuff	A sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy. It is in the form of a polymer cuff with retractable concentric fingers intended to open and grip the colon during pull back (exturbation) to straighten colonic folds and centralize the endoscope within the lumen; it is not intended to hinder intubation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060423410119	GS1
Package	5060423410034	GS1	Carton	8	In Commercial Distribution
Package	5060423410157	GS1	Shipper	120	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	12.1	Millimeter