Anrei

Basic Information

• Brand Name: Anrei
• Primary DI: 06948318912285
• Version / Model: HG-V-2C
• Company Name: Anrei Medical(HZ) Co.,Ltd.
• Labeler DUNS: 529128653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-01
• Public Version: 4
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: 31a7efde-3ab7-4d1d-a91b-08c8b869f22e

Device Description

Single Use Rotatable and Repositionable Hemoclip

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: MR Unsafe
• 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
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61208	Gastrointestinal endoscopic clip, long-term, non-bioabsorbable	A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06948318912285	GS1

Premarket Submissions

Submission Number	Supplement Number
K201771	000