Seal®

Basic Information

• Brand Name: Seal®
• Primary DI: 00840253101068
• Version / Model: SBC-460
• Company Name: ENDOCHOICE, INC.
• Labeler DUNS: 014154279
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 4
• Public Version Date: 2024-01-31
• Public Version Status: Update
• Public Device Record Key: 38aad19c-ba2b-44bb-92b3-77dde2523fe9
• Distribution End Date: 2024-01-30

Device Description

Biopsy Valve

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64366	Endoscopic biopsy valve, reusable	A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840253101068	GS1
Unit of Use	00840253101235	GS1

Customer Contacts

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