FDA.reportPublic FDA data

ZKSK

Primary DI
06934415027298
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
BF19-BC18-1050
Device description
Disposable Biopsy Forceps
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
06934415027298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415027298069344150272986934415027298

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
542947117
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
06934415027274ZKSKBF19-BC18-6002026-09-30
06934415027281ZKSKBF19-BC18-8002026-09-30
06934415027304ZKSKBF19-BC18-12002026-09-30
06934415027311ZKSKBF19-BC18-16002026-09-30
06934415027328ZKSKBF19-BC18-18002026-09-30
06934415027335ZKSKBF19-BC18-20002026-09-30
06934415027342ZKSKBF19-BC18-23002026-09-30
06934415027557ZKSKBF19-EC18-3002026-09-30
06934415027564ZKSKBF19-EC18-5002026-09-30
06934415027571ZKSKBF19-EC18-6002026-09-30
06934415027588ZKSKBF19-EC18-8002026-09-30
06934415027595ZKSKBF19-EC18-10502026-09-30
06934415027601ZKSKBF19-EC18-12002026-09-30
06934415027618ZKSKBF19-EC18-16002026-09-30
06934415027625ZKSKBF19-EC18-18002026-09-30
06934415027632ZKSKBF19-EC18-20002026-09-30
06934415027649ZKSKBF19-EC18-23002026-09-30
06934415027656ZKSKBF19-FC18-3002026-09-30
06934415027663ZKSKBF19-FC18-5002026-09-30
06934415027670ZKSKBF19-FC18-6002026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603211908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211953Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603211977Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212059Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603212103Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224878Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224885Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224892Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224908Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224915Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603224939Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06936603230817Disposable Biopsy ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdFCL2026-10-22
06975339628871Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-10-19
B382SD379410Surgical DirectSurgical Direct, Inc.FCL2026-10-15
06934415027274ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-30
06934415027281ZKSKBeijing 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