FDA.reportPublic FDA data

NA

Primary DI
26926839812349
Brand
NA
Company
Anrei Medical(HZ) Co.,Ltd.
Model
M00591010
Catalog number
M00591010
Device description
Clip
Published
2025-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
26926839812349PackageGS110In Commercial Distribution
26926839812356PackageGS120In Commercial Distribution
16926839812335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2692683981234926926839812349
2692683981235626926839812356
1692683981233516926839812335

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
16926839812304NAM00591000M005910002025-10-27
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
06959664913482NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915387NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915394NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915400NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915417NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915424NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915431NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915448NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915455NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915462NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915479NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915493NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915509NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915516NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915523NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915530NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915547NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915554NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915561NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915578NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915592NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915615NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915622NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915639NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915646NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915653NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915660NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915677NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915684NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915691NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16