Seal®

Basic Information

• Brand Name: Seal®
• Primary DI: 00816849010113
• Version / Model: SBC-365
• Company Name: ENDOCHOICE, INC.
• Labeler DUNS: 014154279
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• 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: aeb9d643-607b-4bbc-beba-dab6bb3bf34d
• Distribution End Date: 2024-01-30

Device Description

Biopsy Valve

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: 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
62145	Endoscopic biopsy valve, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816849010113	GS1
Unit of Use	00840253103031	GS1

Customer Contacts

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