FDA.reportPublic FDA data

NA

Primary DI
06959664910894
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5024-2318
Published
2022-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

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
16959664910891PackageGS110In Commercial Distribution
26959664910898PackageGS110In Commercial Distribution
06959664910894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491089116959664910891
2695966491089826959664910898
06959664910894069596649108946959664910894

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
06936603211908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211953Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211977Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212059Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212103Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224878Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224885Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224892Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224915Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224939Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603230817Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06975339628871Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-10-19
B382SD379410Surgical DirectSurgical Direct, Inc.FCL2026-10-15
06934415027274ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027281ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027298ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027304ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027311ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027328ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027335ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027342ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027557ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027564ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027571ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027588ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027595ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027601ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027618ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027625ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30