FDA.reportPublic FDA data

Single Use Hemoclip

Primary DI
16970401815569
Brand
Single Use Hemoclip
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-C-HR-230-13-090-N
Published
2022-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K212669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212669000Single Use HemoclipZhejiang Chuangxiang Medical Technology Co., Ltd.2022-05-27PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970401815569PackageGS110In Commercial Distribution
26970401811872PackageGS15In Commercial Distribution
06970401814916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181556916970401815569
2697040181187226970401811872
06970401814916069704018149166970401814916

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, short-termA sterile clip intended to be placed short-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. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544434963
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
06936534343020Disposable Ureteral StentsMD-D-JC-6F-26-S2026-09-22
06942804744602Single Use Ureteral Access SheathMD-A-AS-11522026-09-22
06942804744619Single Use Ureteral Access SheathMD-A-AS-11532026-09-22
06942804744626Single Use Ureteral Access SheathMD-A-AS-11542026-09-22
06942804744633Single Use Ureteral Access SheathMD-A-AS-11552026-09-22
06942804744640Single Use Ureteral Access SheathMD-A-AS-10362026-09-22
06942804744657Single Use Ureteral Access SheathMD-A-AS-10372026-09-22
06942804744664Single Use Ureteral Access SheathMD-A-AS-10382026-09-22
06942804744671Single Use Ureteral Access SheathMD-A-AS-10392026-09-22
06942804744688Single Use Ureteral Access SheathMD-A-AS-10402026-09-22
06942804744695Single Use Ureteral Access SheathMD-A-AS-10412026-09-22
06942804744701Single Use Ureteral Access SheathMD-A-AS-10422026-09-22
06942804744718Single Use Ureteral Access SheathMD-A-AS-10432026-09-22
06942804744725Single Use Ureteral Access SheathMD-A-AS-10442026-09-22
06942804744732Single Use Ureteral Access SheathMD-A-AS-10462026-09-22
06942804744749Single Use Ureteral Access SheathMD-A-AS-10472026-09-22
06942804744756Single Use Ureteral Access SheathMD-A-AS-10482026-09-22
06942804744763Single Use Ureteral Access SheathMD-A-AS-10492026-09-22
06942804744770Single Use Ureteral Access SheathMD-A-AS-10502026-09-22
06942804744787Single Use Ureteral Access SheathMD-A-AS-10512026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760441721113Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441721212Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441722110Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441722219Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441723117Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
03760441723216Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
06959664900086NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900178NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900185NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900192NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900291NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900307NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900314NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900543NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900550NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900574NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900598NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900635NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900666NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900697NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900840NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900864NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900871NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900888NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900895NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900901NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900918NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664901144NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664901151NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664902813NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19