FDA.reportPublic FDA data

Disposable Endoscopic Hemoclip

Primary DI
16970057578115
Brand
Disposable Endoscopic Hemoclip
Company
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Model
VDK-CD-16-230-P
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K222146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222146000Disposable Endoscopic HemoclipJiangsu Vedkang Medical Science and Technology Co., Ltd.2023-03-28PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970057578115PackageGS110In Commercial Distribution
26970057578112PackageGS15In Commercial Distribution
56970057578113PackageGS15In Commercial Distribution
66970057578110PackageGS110In Commercial Distribution
06970057578118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697005757811516970057578115
2697005757811226970057578112
5697005757811356970057578113
6697005757811066970057578110
06970057578118069700575781186970057578118

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, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544430136
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
true
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
06941513200089Disposable Non-electric Biopsy ForcepsVDK-FB-30-230-O-P1-B12026-05-22
06941513222692Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P-A22026-05-22
06941513222708Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P1-A22026-05-22
06941513222715Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P-A22026-05-22
06941513222722Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A22026-05-22
06970057578248Disposable Cleaning BrushVDK-CB-06-230-C2026-05-22
06970057578286Polyp TrapsVDK-PT-052026-05-22
06970057579023Disposable Grasping ForcepsVDK-FG-23-230-A12026-05-22
06970057571027Stone Extraction BalloonVDK-BAL-23-11/13/15-B2026-04-14
06970057577937Disposable SphincterotomeVDK-KE-3025110-A2026-04-14
06970057579061Disposable Grasping ForcepsVDK-FG-23-230-A42026-03-25
06970057573014VedBasket, Stone Extraction BasketsVDK-BAS-23-200-30-S4-A2024-08-20
06970057575032Disposable Polyp SnareVDK-SD-23-230-35-A12024-08-20
06970057578040Disposable Endoscopic HemoclipVDK-CD-13-230-P2024-08-20
06970057578118Disposable Endoscopic HemoclipVDK-CD-16-230-P2024-08-20
06970057573021VedBasket, Stone Extraction BasketsVDK-BAS-23-200-35-S4-A2024-08-20
06970057578002Disposable Endoscopic HemoclipVDK-CD-11-230-P2024-08-20
06970057574486Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
16970057574483Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
06941513210972Disposable Non-electric Biopsy ForcepsVDK-FB-18-70-O-P-B12025-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664915868NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915875NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915882NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915899NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915912NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915936NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915943NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915950NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915967NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915974NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915981NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916094NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916100NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916117NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916124NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916131NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916292NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916308NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916315NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916322NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916339NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916346NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916353NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916360NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916490NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916506NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916513NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916520NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916537NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916698NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23