FDA.reportPublic FDA data

ZKSK

Primary DI
06934415024785
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
BF19-AP23-300
Device description
Disposable Biopsy Forceps
Published
2026-09-24
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
06934415024785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415024785069344150247856934415024785

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
Ethylene Oxide

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934415023009ZKSKBF19-DP23-23002026-09-24
06934415023467ZKSKBF19-DC23-23002026-09-24
06934415023474ZKSKBF19-FP23-23002026-09-24
06934415024792ZKSKBF19-AP23-5002026-09-24
06934415024808ZKSKBF19-AP23-6002026-09-24
06934415024815ZKSKBF19-AP23-8002026-09-24
06934415024822ZKSKBF19-AP23-10502026-09-24
06934415024839ZKSKBF19-AP23-12002026-09-24
06934415024846ZKSKBF19-AP23-16002026-09-24
06934415024853ZKSKBF19-AP23-18002026-09-24
06934415024860ZKSKBF19-AP23-20002026-09-24
06934415024877ZKSKBF19-AP23-23002026-09-24
06934415024884ZKSKBF19-BP23-3002026-09-24
06934415024891ZKSKBF19-BP23-5002026-09-24
06934415024907ZKSKBF19-BP23-6002026-09-24
06934415024914ZKSKBF19-BP23-8002026-09-24
06934415024921ZKSKBF19-BP23-10502026-09-24
06934415024938ZKSKBF19-BP23-12002026-09-24
06934415024945ZKSKBF19-BP23-16002026-09-24
06934415024952ZKSKBF19-BP23-18002026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934415023009ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415023467ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415023474ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024792ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024808ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024815ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024822ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024839ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024846ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024853ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024860ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024877ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024884ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024891ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024907ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024914ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024921ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024938ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024945ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024952ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024969ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024976ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024983ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415024990ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415025003ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415025010ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415025027ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415025034ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415025041ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24
06934415025058ZKSKBeijing ZKSK Technology Co.,LtdFCL2026-09-24