PROXIMATE

Basic Information

• Brand Name: PROXIMATE
• Primary DI: 20705036001314
• Version / Model: CAD38
• Catalog Number: CAD38
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 3
• Public Version Date: 2021-08-20
• Public Version Status: Update
• Public Device Record Key: 4bfae888-f919-4858-bf2a-8a93104cc588
• Distribution End Date: 2021-08-19

Device Description

Proximate Circular Anal Dilators (CAD)

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: Yes
• 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
FFP	DILATOR, RECTAL	Gastroenterology, Urology	876.5450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58007	Rectal dilator, single-use	A sterile surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30705036001311	GS1	CASE	36	Not in Commercial Distribution	2021-08-19
Primary	20705036001314	GS1
Unit of Use	10705036001317	GS1

Customer Contacts

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