Andorate

Basic Information

• Brand Name: Andorate
• Primary DI: 06970661241538
• Version / Model: GAR018-S
• Company Name: Smartdata Suzhou Co., Ltd.
• Labeler DUNS: 529507479
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-26
• Public Version: 1
• Public Version Date: 2019-09-03
• Public Version Status: New
• Public Device Record Key: 43d6771e-0c2f-4a13-83cd-92b94fec5c8d

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: 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
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60757	Endoscopic biopsy valve, sterile	A sterile 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 a water input valve for simultaneous irrigation/biopsy. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26970661241532	GS1	Carton	10	In Commercial Distribution
Package	16970661241535	GS1	Outer Box	100	In Commercial Distribution
Primary	06970661241538	GS1