FDA.reportPublic FDA data

Single-Use Biopsy Forceps

Primary DI
06975339628536
Brand
Single-Use Biopsy Forceps
Company
MacroLux Medical Technology Co., Ltd.
Model
BF-F-1.8×600-O
Device description
Single-Use Biopsy Forceps, BF-F-1.8×600-O
Published
2026-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
16975339628533PackageGS110In Commercial Distribution
26975339628530PackageGS112In Commercial Distribution
06975339628536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697533962853316975339628533
2697533962853026975339628530
06975339628536069753396285366975339628536

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
723490133
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
false
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
06975339623418SeleneView®HO422026-07-03
06975339628406Single-Use Biopsy ForcepsBF-S-1.6×3802026-07-03
06975339628413Single-Use Alligator GrasperGF-S-1.6×3802026-07-03
06975339628420Single-use Endoscopic ScissorsPS-S-1.6×3802026-07-03
06975339628512Single-Use Biopsy ForcepsBF-F-1.8×6002026-07-03
06975339628529Single-Use Biopsy ForcepsBF-F-1.8×600-G2026-07-03
06975339628550Single-Use Grasping ForcepsGF-F-1.8×6002026-07-03
06975339628567Single-Use Grasping ForcepsGF-F-1.8×600-G2026-07-03
06975339628574Single-Use Grasping ForcepsGF-F-1.8×600-O2026-07-03
06975339628598Single-Use Biopsy ForcepsBF-S-1.6×380-G2026-07-03
06975339628604Single-Use Biopsy ForcepsBF-S-1.6×380-O2026-07-03
06975339628611Single-Use Alligator GrasperGF-S-1.6×380-G2026-07-03
06975339628628Single-Use Alligator GrasperGF-S-1.6×380-O2026-07-03
06975339628635Single-use Endoscopic ScissorsPS-S-1.6×380-G2026-07-03
06975339628642Single-use Endoscopic ScissorsPS-S-1.6×380-O2026-07-03
06975339620318CoralView®U10-B2024-03-12
06975339620325CoralView®U10-BR2024-03-12
06975339620332CoralView®U202024-03-28
06975339620349CoralView®U20-B2024-03-28
06975339620356CoralView®U20-BR2024-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664900000NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900215NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900222NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910788NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910801NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910832NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910863NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911365NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911372NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911389NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911396NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944035NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944042NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944059NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944066NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944073NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944080NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944097NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944103NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944110NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944127NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944134NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944141NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944165NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944172NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06975339628512Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628529Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628550Single-Use Grasping ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628567Single-Use Grasping ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628574Single-Use Grasping ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03