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

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, single-useA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

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
00724995346379V. MuellerSTERIS Deutschland GmbHFCL2026-09-25
00724995346386V. MuellerSTERIS Deutschland GmbHFCL2026-09-25
06934415023009ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415023467ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415023474ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024785ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024792ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024808ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024815ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024822ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024839ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024846ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024853ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024860ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024877ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024884ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024891ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024907ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024914ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024921ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024938ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024945ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024952ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024969ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024976ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024983ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024990ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415025003ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415025010ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415025027ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24