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
06970401812110Single Use Grasping ForcepsMD-C-GF18062023-02-07
06970401813490Single Use GuidewireMD-S-GW35452019-03-23
06970401813766Single Use GuidewireMD-A-GW35452021-09-27
06970401815661Single Use GuidewireMD-S-GW25452020-06-17
06936534325439Single Use Urinary GuidewireMD-A1-UW21182023-11-27
06936534325446Single Use Urinary GuidewireMD-A1-UW21202023-11-27
06936534325453Single Use Urinary GuidewireMD-A1-UW21262023-11-27
06936534325460Single Use Urinary GuidewireMD-A1-UW25052023-11-27
06936534325477Single Use Urinary GuidewireMD-A1-UW25102023-11-27
06936534325484Single Use Urinary GuidewireMD-A1-UW25122023-11-27
06936534325491Single Use Urinary GuidewireMD-A1-UW25152023-11-27
06936534325507Single Use Urinary GuidewireMD-A1-UW25182023-11-27
06936534325514Single Use Urinary GuidewireMD-A1-UW25202023-11-27
06936534325521Single Use Urinary GuidewireMD-A1-UW25262023-11-27
06936534325538Single Use Urinary GuidewireMD-A1-UW28052023-11-27
06936534325545Single Use Urinary GuidewireMD-A1-UW28102023-11-27
06936534325552Single Use Urinary GuidewireMD-A1-UW28122023-11-27
06936534325569Single Use Urinary GuidewireMD-A1-UW28152023-11-27
06936534325576Single Use Urinary GuidewireMD-A1-UW28182023-11-27
06936534325583Single Use Urinary GuidewireMD-A1-UW28202023-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06959664902820NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664902837NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664902851NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664969526NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664969533NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664969540NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19