FDA.reportPublic FDA data

NA

Primary DI
16926839812304
Brand
NA
Company
Anrei Medical(HZ) Co.,Ltd.
Model
M00591000
Catalog number
M00591000
Device description
Clip
Published
2025-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201771000Single Use Rotatable and Repositionable HemoclipAnrei Medical (Hangzhou) Co., Ltd.2020-10-19PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26926839812318PackageGS110In Commercial Distribution
26926839812325PackageGS120In Commercial Distribution
16926839812304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2692683981231826926839812318
2692683981232526926839812325
1692683981230416926839812304

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, long-term, non-bioabsorbableA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529128653
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16948318903921RescueM00515100M005151002021-05-14
16948318903822RescueM00527450M005274502019-03-01
16948318903907RescueM00527650M005276502019-02-28
16948318903938RescueM00527750M005277502019-02-28
16948318903983RescueM00538350M005383502019-03-01
16948318968807RescueM00527550M005275502019-02-28
16926839812335NAM00591010M005910102025-10-27
16926839812366NAM00591200M005912002025-10-27
16926839812397NAM00591210M005912102025-10-27
16926839812427NAM00591220M005912202025-10-27
16926839812458NAM00591230M005912302025-10-27
16926839812489NAM00591240M005912402025-10-27
16926839812519NAM00591250M005912502025-10-27
26926839812349NAM00591010M005910102025-10-27
26926839812370NAM00591200M005912002025-10-27
26926839812400NAM00591210M005912102025-10-27
26926839812431NAM00591220M005912202025-10-27
26926839812462NAM00591230M005912302025-10-27
26926839812493NAM00591240M005912402025-10-27
26926839812523NAM00591250M005912502025-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664917299NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917305NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917312NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917329NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917336NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919712NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919729NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919736NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919743NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919750NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920169NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920176NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920183NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920190NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920206NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920305NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920312NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920329NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920336NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920343NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920350NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920510NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920527NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920534NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920541NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920558NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920763NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920770NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920787NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920794NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07