FDA.reportPublic FDA data

Single-Use Biopsy Forceps

Primary DI
06975339628529
Brand
Single-Use Biopsy Forceps
Company
MacroLux Medical Technology Co., Ltd.
Model
BF-F-1.8×600-G
Device description
Single-Use Biopsy Forceps, BF-F-1.8×600-G
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
16975339628526PackageGS110In Commercial Distribution
06975339628529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697533962852616975339628526
06975339628529069753396285296975339628529

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
06975339621506BubbleViewC38-CS2026-08-14
06975339621513BubbleViewC38-CRS2026-08-14
06975339621520BubbleViewC50-CB2026-08-14
06975339621537BubbleViewC50-CBR2026-08-14
06975339621926BubbleViewC38-CS2026-08-14
06975339621933BubbleViewC38-CRS2026-08-14
06975339621964BubbleViewC50-CB2026-08-14
06975339621971BubbleViewC50-CBR2026-08-14
06975339621179BubbleView®C50-C2024-07-10
06975339621186BubbleView®C50-CR2024-07-10
06975339621940BubbleView®C50-C2025-09-05
06975339621957BubbleViewC50-CR2025-09-05
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
06975339628536Single-Use Biopsy ForcepsBF-F-1.8×600-O2026-07-03
06975339628550Single-Use Grasping ForcepsGF-F-1.8×6002026-07-03
06975339628567Single-Use Grasping ForcepsGF-F-1.8×600-G2026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD379410Surgical DirectSurgical Direct, Inc.FCL2026-10-15
06934415027274ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027281ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027298ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027304ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027311ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027328ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027335ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027342ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027557ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027564ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027571ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027588ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027595ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027601ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027618ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027625ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027632ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027649ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027656ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027663ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027670ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027687ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027694ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027700ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027717ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027724ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027731ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027748ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027755ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30