FDA.reportPublic FDA data

NA

Primary DI
06959664911259
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5076-241523
Published
2019-04-24
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664911256PackageGS110In Commercial Distribution
26959664911253PackageGS110In Commercial Distribution
36959664911250PackageGS12Not in Commercial Distribution
46959664911257PackageGS125Not in Commercial Distribution
56959664911254PackageGS15Not in Commercial Distribution
66959664911251PackageGS110Not in Commercial Distribution
06959664911259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491125616959664911256
2695966491125326959664911253
3695966491125036959664911250
4695966491125746959664911257
5695966491125456959664911254
6695966491125166959664911251
06959664911259069596649112596959664911259

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

Regulatory Flags#

DUNS number
542984702
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664913482NAAG-55501-1800-090-132026-07-16
06959664915387NAAG-55501-1650-090-112026-07-16
06959664915394NAAG-55501-1650-090-132026-07-16
06959664915400NAAG-55501-1650-090-162026-07-16
06959664915417NAAG-55501-1650-090-92026-07-16
06959664915424NAAG-55501-1650-135-112026-07-16
06959664915431NAAG-55501-1650-135-132026-07-16
06959664915448NAAG-55501-1650-135-162026-07-16
06959664915455NAAG-55501-1650-135-92026-07-16
06959664915462NAAG-55501-1950-090-112026-07-16
06959664915479NAAG-55501-1950-090-132026-07-16
06959664915493NAAG-55501-1950-090-92026-07-16
06959664915509NAAG-55501-1950-135-112026-07-16
06959664915516NAAG-55501-1950-135-132026-07-16
06959664915523NAAG-55501-1950-135-162026-07-16
06959664915530NAAG-55501-1950-135-92026-07-16
06959664915547NAAG-55501-2300-090-112026-07-16
06959664915554NAAG-55501-2300-090-132026-07-16
06959664915561NAAG-55501-2300-090-162026-07-16
06959664915578NAAG-55501-2300-090-92026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664913482NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915387NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915394NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915400NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915417NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915424NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915431NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915448NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915455NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915462NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915479NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915493NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915509NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915516NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915523NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915530NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915547NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915554NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915561NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915578NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915592NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915615NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915622NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915639NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915646NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915653NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915660NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915677NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915684NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915691NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16