FDA.reportPublic FDA data

NA

Primary DI
66959664910797
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5021-2323
Published
2019-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K172727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172727000HemoclipHangzhou AGS MedTech Co., Ltd.2018-04-16PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664910792PackageGS110In Commercial Distribution
26959664910799PackageGS110In Commercial Distribution
36959664910796PackageGS12In Commercial Distribution
46959664910793PackageGS125In Commercial Distribution
56959664910790PackageGS15In Commercial Distribution
66959664910797PackageGS110In Commercial Distribution
06959664910795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491079216959664910792
2695966491079926959664910799
3695966491079636959664910796
4695966491079346959664910793
5695966491079056959664910790
6695966491079766959664910797
06959664910795069596649107956959664910795

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542984702
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
true
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
06959664917299NAAG-55505-1650-090-9-12026-08-07
06959664917305NAAG-55505-1650-090-9-22026-08-07
06959664917312NAAG-55505-1650-090-9-32026-08-07
06959664917329NAAG-55505-1650-090-9-42026-08-07
06959664917336NAAG-55505-1650-090-9-52026-08-07
06959664919712NAAG-55504-1650-135-18-12026-08-07
06959664919729NAAG-55504-1650-135-18-22026-08-07
06959664919736NAAG-55504-1650-135-18-32026-08-07
06959664919743NAAG-55504-1650-135-18-42026-08-07
06959664919750NAAG-55504-1650-135-18-52026-08-07
06959664920169NAAG-55504-1800-135-18-12026-08-07
06959664920176NAAG-55504-1800-135-18-22026-08-07
06959664920183NAAG-55504-1800-135-18-32026-08-07
06959664920190NAAG-55504-1800-135-18-42026-08-07
06959664920206NAAG-55504-1800-135-18-52026-08-07
06959664920305NAAG-55504-1950-090-18-52026-08-07
06959664920312NAAG-55504-1950-135-18-12026-08-07
06959664920329NAAG-55504-1950-135-18-22026-08-07
06959664920336NAAG-55504-1950-135-18-32026-08-07
06959664920343NAAG-55504-1950-135-18-42026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664917299NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917305NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917312NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917329NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917336NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919712NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919729NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919736NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919743NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919750NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920169NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920176NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920183NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920190NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920206NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920305NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920312NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920329NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920336NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920343NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920350NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920510NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920527NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920534NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920541NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920558NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920763NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920770NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920787NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920794NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07