Anrei

GUDID 06948318912322

Anrei Medical(HZ) Co.,Ltd.

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Primary Device ID06948318912322
NIH Device Record Keya5c1b80c-b2af-454f-a5b8-e095717356c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnrei
Version Model NumberHG-III-2CVM
Company DUNS529128653
Company NameAnrei Medical(HZ) Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106948318912322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKLHemostatic Metal Clip For The Gi Tract

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-11-01

On-Brand Devices [Anrei]

06948318912346HG-VII-5CVM
06948318912339HG-V-2CVM
06948318912322HG-III-2CVM
06948318912315HG-II-5CVM
06948318912308HG-VII-2C
06948318912292HG-III-2C
06948318912285HG-V-2C
06948318912278HG-II-2C
26948318968828M00515101
16948318903921M00515100
06926839806078Single-use Biopsy Foreps
06926839806061Single-use Biopsy Foreps
06926839806054Single-use Biopsy Foreps
06926839806047Single-use Biopsy Foreps
06926839806030Single-use Biopsy Foreps
06926839806023Single-use Biopsy Foreps
06926839806016Single-use Biopsy Foreps
06926839806009Single-use Biopsy Foreps
06948318963096Single Use Rotatable and Repositionable Hemoclip
06948318963089Single Use Rotatable and Repositionable Hemoclip
06948318963126Single use stone retrieval basket
06948318963119Stone Retrieval Balloon Catheter
06948318963102Stone Retrieval Balloon Catheter
06948318938032Single-use Cold Snare
06926839809246Single Use Endoscope Valves Set
06926839809178Single use Grasping Forceps
06926839809161Single Use Injection Needle
06926839809154Single Use Injection Needle
06926839809130Single Use Injection Needle
06926839807686Single Use Rotatable and Repositionable Hemoclip
06926839800595Bite Block
06926839800588Single-use Biopsy Forceps
06926839800571Single-use Biopsy Forceps
06926839809147Single Use Injection Needle

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.