FDA.reportPublic FDA data

Disposable Hemostatic Clips

Primary DI
16974529069019
Brand
Disposable Hemostatic Clips
Company
Ningbo Xinwell Medical Technology Co., Ltd.
Model
XY-ZZJ-1B-2.5-2700-90-11
Device description
Disposable Hemostatic Clips
Published
2024-11-29
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
K232969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232969000Disposable Hemostatic ClipsNingbo Xinwell Medical Technology Co., Ltd.2024-06-07PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974529069019PackageGS110In Commercial Distribution
26974529069016PackageGS15In Commercial Distribution
06974529069012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697452906901916974529069019
2697452906901626974529069016
06974529069012069745290690126974529069012

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
544587864
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971944910141Closed Suction CathetersH1064002025-03-04
06971944910158Closed Suction CathetersH1084002025-03-04
06971944910165Closed Suction CathetersH1104002025-03-04
06971944910172Closed Suction CathetersH1124002025-03-04
06971944910189Closed Suction CathetersH1144002025-03-04
06971944910196Closed Suction CathetersH1164002025-03-04
06971944910202Closed Suction CathetersH1184002025-03-04
06971944910219Closed Suction CathetersH1106002025-03-04
06971944910226Closed Suction CathetersH1126002025-03-04
06971944910233Closed Suction CathetersH1146002025-03-04
06971944910240Closed Suction CathetersH1166002025-03-04
06971944910257Closed Suction CathetersH1186002025-03-04
06971944910264Closed Suction CathetersH2064002025-03-04
06971944910271Closed Suction CathetersH2084002025-03-04
06971944910288Closed Suction CathetersH2104002025-03-04
06971944910295Closed Suction CathetersH2124002025-03-04
06971944910301Closed Suction CathetersH2144002025-03-04
06971944910318Closed Suction CathetersH2164002025-03-04
06971944910325Closed Suction CathetersH2184002025-03-04
06971944910332Closed Suction CathetersH2106002025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664915998NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916001NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916018NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916025NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916032NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916049NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916056NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916063NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916070NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916087NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916148NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916155NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916162NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916179NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916186NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916193NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916209NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916216NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916223NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916230NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916247NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916254NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916261NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916278NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916285NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916377NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916384NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916391NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916407NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916414NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31