FDA.reportPublic FDA data

Disposable Endoscopic Biopsy Forceps

Primary DI
16971944915204
Brand
Disposable Endoscopic Biopsy Forceps
Company
Ningbo Xinwell Medical Technology Co., Ltd.
Model
AD2407BTCP-A
Device description
Disposable Endoscopic Biopsy Forceps
Published
2024-12-20
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971944915204PackageGS110In Commercial Distribution
26971944915201PackageGS15In Commercial Distribution
06971944915207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697194491520416971944915204
2697194491520126971944915201
06971944915207069719449152076971944915207

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544587864
Device count
1
DM exempt
false
Premarket exempt
true
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
06971944910141Closed Suction CathetersH1064002025-03-04
06971944910158Closed Suction CathetersH1084002025-03-04
06971944910165Closed Suction CathetersH1104002025-03-04
06971944910172Closed Suction CathetersH1124002025-03-04
06971944910189Closed Suction CathetersH1144002025-03-04
06971944910196Closed Suction CathetersH1164002025-03-04
06971944910202Closed Suction CathetersH1184002025-03-04
06971944910219Closed Suction CathetersH1106002025-03-04
06971944910226Closed Suction CathetersH1126002025-03-04
06971944910233Closed Suction CathetersH1146002025-03-04
06971944910240Closed Suction CathetersH1166002025-03-04
06971944910257Closed Suction CathetersH1186002025-03-04
06971944910264Closed Suction CathetersH2064002025-03-04
06971944910271Closed Suction CathetersH2084002025-03-04
06971944910288Closed Suction CathetersH2104002025-03-04
06971944910295Closed Suction CathetersH2124002025-03-04
06971944910301Closed Suction CathetersH2144002025-03-04
06971944910318Closed Suction CathetersH2164002025-03-04
06971944910325Closed Suction CathetersH2184002025-03-04
06971944910332Closed Suction CathetersH2106002025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941513200089Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222692Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222708Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222715Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
06941513222722Disposable Non-electric Biopsy ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.FCL2026-05-22
00190776418021MillenniumAvalign Technologies, Inc.FCL2026-03-23
06970671381569AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2026-03-23
G3731433010Zinnanti SurgicalZinnanti Surgical Design Group IncFCL2026-03-04
00190776415617MillenniumAvalign Technologies, Inc.FCL2026-01-28
18051887049841THD BIOPSYTHD SPAFCL2026-01-07
18051887049865THD BIOPSYTHD SPAFCL2026-01-07
18051887049889THD BIOPSYTHD SPAFCL2026-01-07
06970671381026AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381040AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381187AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381200AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381248AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381323AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381347AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381477AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381491AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381545AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970800684059AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-12-29
06970671381361AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-08-08
06970671381385AltonAlton (Shanghai) Medical Instruments Co., Ltd.FCL2025-08-08
00194613029449MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613029456MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613029463MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613029470MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613034511MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01