FDA.report

G-Flex

Primary DI
05420051306404
Brand
G-Flex
Company
G-Flex Europe
Model
U422-180S
Device description
Disposable Biopsy Forceps - SharkBite
Published
2025-06-02
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

Related Records

Product Codes

CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications

CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05420051306404PackageGS110In Commercial Distribution
05420051306114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05420051306404054200513064045420051306404
05420051306114054200513061145420051306114

GMDN Terms

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

Regulatory Flags

DUNS number
763193690
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 DIBrandModelCatalogPublished
05420051305209G-FlexGF2522022025-06-02
05420051305216G-FlexGF2522032025-06-02
05420051305247G-FlexGF2623022025-06-02
05420051305544G-FlexU160C2025-06-02
05420051305568G-FlexU160SC2025-06-02
05420051305834G-FlexU230C2025-06-02
05420051305599G-FlexU230SC2025-06-02
05420051305629G-FlexU422-1802025-06-02
05420051305636G-FlexU422-2302025-06-02
05420051305537G-FlexU120C2025-06-02
05420051302512G-FlexU160PC2025-06-02
05420051305995G-FlexU422-230LC2025-06-02
05420051306008G-FlexGF252203-252025-06-02
05420051306640G-FlexU1602025-06-02
05420051306633G-FlexU2302025-06-02
05420051306398G-FlexU422-230S2025-06-02

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Primary DIBrandCompanyProduct codePublished
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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
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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
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00194613077471MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613077938MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613082642MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01
00194613082796MSI Precision Specialty InstrumentsMed Saver, Inc.FCL2025-08-01