M00591010

GUDID 26926839812349

Clip

Anrei Medical(HZ) Co.,Ltd.

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Primary Device ID26926839812349
NIH Device Record Keyecd5b491-6c80-4cb1-bf02-897f61d1a3d0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberM00591010
Catalog NumberM00591010
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116926839812335 [Primary]
GS126926839812349 [Package]
Contains: 16926839812335
Package: [10 Units]
In Commercial Distribution
GS126926839812356 [Package]
Contains: 16926839812335
Package: [20 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-12-11
Device Publish Date2025-10-27

Devices Manufactured by Anrei Medical(HZ) Co.,Ltd.

16926839812304 - NA2025-12-11 Clip
26926839812349 - NA2025-12-11Clip
26926839812349 - NA2025-12-11 Clip
26926839812370 - NA2025-12-11 Single-Use Snare
26926839812400 - NA2025-12-11 Single-Use Snare
26926839812431 - NA2025-12-11 Single-Use Snare
26926839812462 - NA2025-12-11 Single-Use Snare
26926839812493 - NA2025-12-11 Single-Use Snare
26926839812523 - NA2025-12-11 Single-Use Snare

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