FDA.reportPublic FDA data

Single Use Hemoclip

Primary DI
26970401813715
Brand
Single Use Hemoclip
Company
Zhe Jiang ChuangXiang Medical Technology Co., Ltd.
Model
MD-G-HR-230-12-135-N
Published
2019-01-08
Public version status
New
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
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
16970401813701PackageGS110In Commercial Distribution
26970401813715PackageGS15In Commercial Distribution
06970401813698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697040181370116970401813701
2697040181371526970401813715
06970401813698069704018136986970401813698

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
16970401815095Disposable Valve SetsMD-B-AW012020-04-23
26970401814286Non-Rotatable SnaresMD-E-SNC2415242019-10-23
26970401814262Non-Rotatable SnaresMD-E-SNC2432242019-10-23
26970401814309Rotatable SnaresMD-E-SNR2415242019-10-23
26970401813739Cleaning BrushMD-A-BR-23062019-01-09
26970401813456Cleaning BrushMD-B-BR-23062018-11-23
26970401813470Cleaning BrushMD-B-BR-05102018-11-23
26970401813647Cleaning BrushMD-D-BR-05102018-12-10
26970401814248Single Use Biopsy ForcepsMD-B-BF24182019-09-25
26970401813975Single Use Biopsy ForcepsMD-C-BF24032019-06-04
26970401814002Single Use Grasping ForcepsMD-C-GF24032019-06-04
26970401813944Single Use Biopsy ForcepsMD-A-BF24182019-04-29
26970401812862Single Use HemoclipMD-L-HR-270-15-135-Y2019-03-22
26970401813913Single Use GuidewireMD-S-GW35452019-03-23
26970401813890Single Use HemoclipMD-C-HR-270-13-135-Y2019-03-22
26970401813401Single Use Biopsy ForcepsMD-A-BF24162019-02-26
26970401813845Disposable Bite BlockMD-BB-CY-012019-02-26
26970401813210Rotatable SnaresMD-E-SNR2432242018-09-25
16970401813671Single Use Biopsy ForcepsMD-B-BF24232019-01-04
26970401813517Single Use Biopsy ForcepsMD-A-BF24232018-12-03

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