FDA.reportPublic FDA data

Anrei

Primary DI
06948318912308
Brand
Anrei
Company
Anrei Medical(HZ) Co.,Ltd.
Model
HG-VII-2C
Published
2020-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
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
06948318912308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948318912308069483189123086948318912308

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, and/or for treating mucosal/submucosal defects. 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
26926839812349NAM00591010M005910102025-10-27
26926839812370NAM00591200M005912002025-10-27
26926839812400NAM00591210M005912102025-10-27
26926839812431NAM00591220M005912202025-10-27
26926839812462NAM00591230M005912302025-10-27
26926839812493NAM00591240M005912402025-10-27

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