FDA.reportPublic FDA data

Disposable Endoscopic Biopsy Forceps

Primary DI
16971944916300
Brand
Disposable Endoscopic Biopsy Forceps
Company
Ningbo Xinwell Medical Technology Co., Ltd.
Model
AD2412BTS-B
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
16971944916300PackageGS110In Commercial Distribution
26971944916307PackageGS15In Commercial Distribution
06971944916303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697194491630016971944916300
2697194491630726971944916307
06971944916303069719449163036971944916303

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
26971944910145Closed Suction CathetersH1064002025-03-04
26971944910152Closed Suction CathetersH1084002025-03-04
26971944910169Closed Suction CathetersH1104002025-03-04
26971944910176Closed Suction CathetersH1124002025-03-04
26971944910183Closed Suction CathetersH1144002025-03-04
26971944910190Closed Suction CathetersH1164002025-03-04
26971944910206Closed Suction CathetersH1184002025-03-04
26971944910213Closed Suction CathetersH1106002025-03-04
26971944910220Closed Suction CathetersH1126002025-03-04
26971944910237Closed Suction CathetersH1146002025-03-04
26971944910244Closed Suction CathetersH1166002025-03-04
26971944910251Closed Suction CathetersH1186002025-03-04
26971944910268Closed Suction CathetersH2064002025-03-04
26971944910275Closed Suction CathetersH2084002025-03-04
26971944910282Closed Suction CathetersH2104002025-03-04
26971944910299Closed Suction CathetersH2124002025-03-04
26971944910305Closed Suction CathetersH2144002025-03-04
26971944910312Closed Suction CathetersH2164002025-03-04
26971944910329Closed Suction CathetersH2184002025-03-04
26971944910336Closed 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