Sephure® suppository applicator

Basic Information

• Brand Name: Sephure® suppository applicator
• Primary DI: 00868648000031
• Version / Model: A2-10
• Company Name: Cristcot LLC
• Labeler DUNS: 080739421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-09-28
• Public Version: 1
• Public Version Date: 2021-10-06
• Public Version Status: New
• Public Device Record Key: e4bea076-3c17-44ef-a1c4-8e11957250ab

Device Description

A2 10-pouch - rectal suppository applicator, USA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
OOW	Applicator For Rectal Suppository	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61327	Rectal medication applicator, single-use	A non-sterile instrument intended to be inserted into the rectum for the application of medication to treat local or systemic disease/conditions. It is a plastic device which may be in the form of a short tube to be connected to a cream medication tube, or a fluted tube with a plunger to administer a suppository. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00868648000000	GS1
Primary	00868648000031	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092829	000