Anrei

GUDID 06948318912278

Anrei Medical(HZ) Co.,Ltd.

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Primary Device ID06948318912278
NIH Device Record Key265a832d-60d4-427e-9f76-bb6d07f4eaf7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnrei
Version Model NumberHG-II-2C
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
GS106948318912278 [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

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