FDA.reportPublic FDA data

NA

Primary DI
16959664914066
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5101-2300-135
Published
2022-10-09
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
16959664914066PackageGS110In Commercial Distribution
26959664914063PackageGS1100In Commercial Distribution
06959664914069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491406616959664914066
2695966491406326959664914063
06959664914069069596649140696959664914069

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
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
06959664944677NAAG-5033-14162026-08-21
06959664900086NAAG-51061-1650-090-92026-08-19
06959664900178NAAG-51061-1800-090-92026-08-19
06959664900185NAAG-51061-1950-090-92026-08-19
06959664900192NAAG-51061-2150-090-92026-08-19
06959664900291NAAG-51061-2300-090-92026-08-19
06959664900307NAAG-51061-1650-135-92026-08-19
06959664900314NAAG-51061-1800-135-92026-08-19
06959664900543NAAG-51061-1950-135-92026-08-19
06959664900550NAAG-51061-2150-135-92026-08-19
06959664900574NAAG-51061-2300-135-92026-08-19
06959664900598NAAG-51063-1650-090-132026-08-19
06959664900635NAAG-51063-1800-090-132026-08-19
06959664900666NAAG-51063-1950-090-132026-08-19
06959664900697NAAG-51063-1950-090-132026-08-19
06959664900840NAAG-51063-1950-090-132026-08-19
06959664900864NAAG-51063-1650-135-132026-08-19
06959664900871NAAG-51063-1800-135-132026-08-19
06959664900888NAAG-51063-1950-135-132026-08-19
06959664900895NAAG-51063-2150-135-132026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603238059HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
06936603238066HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
06936603238073HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
16926839818887NAAnrei Medical(HZ)Co., Ltd.PKL2026-10-19
16926839818917NAAnrei Medical(HZ)Co., Ltd.PKL2026-10-19
03760441721113Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441721212Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441722110Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441722219Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441723117Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
03760441723216Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
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