FDA.reportPublic FDA data

Single Use Hemoclip

Primary DI
06970401811212
Brand
Single Use Hemoclip
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-G-HR-230-12-135-Y
Published
2018-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K172762000
K212669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172762000Single Use HemoclipZhejiang Chuangxiang Medical Technology Co., Ltd.2018-03-20PKL
K212669000Single Use HemoclipZhejiang Chuangxiang Medical Technology Co., Ltd.2022-05-27PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970401813220PackageGS110In Commercial Distribution
26970401813234PackageGS15In Commercial Distribution
06970401811212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181322016970401813220
2697040181323426970401813234
06970401811212069704018112126970401811212

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936534328911Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1810242026-09-29
06936534328928Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1810182026-09-29
06936534328935Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1815242026-09-29
06936534328942Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1815182026-09-29
06936534328959Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1825242026-09-29
06936534328966Polypectomy Snare (NON-ELECTRICAL)MD-E-FL1825182026-09-29
06936534328973Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2410242026-09-29
06936534328980Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2410182026-09-29
06936534328997Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2415242026-09-29
06936534329000Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2415182026-09-29
06936534329017Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2425242026-09-29
06936534329024Polypectomy Snare (NON-ELECTRICAL)MD-E-FL2425182026-09-29
06936534329031Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1810242026-09-29
06936534329048Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1810182026-09-29
06936534329055Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1815242026-09-29
06936534329062Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1815182026-09-29
06936534329079Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1825242026-09-29
06936534329086Polypectomy Snare (NON-ELECTRICAL)MD-H-FL1825182026-09-29
06936534329093Polypectomy Snare (NON-ELECTRICAL)MD-H-FL2410242026-09-29
06936534329109Polypectomy Snare (NON-ELECTRICAL)MD-H-FL2410182026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603238059HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
06936603238066HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
06936603238073HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
16926839818887NAAnrei Medical(HZ) Co.,Ltd.PKL2026-10-19
16926839818917NAAnrei Medical(HZ) Co.,Ltd.PKL2026-10-19
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