FDA.reportPublic FDA data

ZKSK

Primary DI
06934415022118
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
HF18-18/180
Device description
Disposable Hot Biopsy Forceps
Published
2023-12-18
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGEForceps, Biopsy, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGEForceps, Biopsy, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934415022118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415022118069344150221186934415022118

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+86 13260186661barbie@bjzksk.com

Regulatory Flags#

DUNS number
542947117
Device count
1
DM exempt
false
Premarket exempt
false
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
true
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
16934415066621ZKSKBL18-8A2024-12-06
16934415066638ZKSKBL18-4A2024-12-06
16934415066645ZKSKBL18-5A2024-12-06
16934415066652ZKSKBL18-6A2024-12-06
16934415066669ZKSKBL18-7A2024-12-06
16934415066676ZKSKBL18-9A2024-12-06
06934415011334ZKSKBF18-A23/2302024-04-12
06934415011341ZKSKBF18-A23/50P2024-04-12
06934415011358ZKSKBF18-A23/120P2024-04-12
06934415011365ZKSKBF18-A23/160P2024-04-12
06934415011372ZKSKBF18-A23/180P2024-04-12
06934415011389ZKSKBF18-A23/230P2024-04-12
06934415011396ZKSKBF18-F18/50-J2024-04-12
06934415011402ZKSKBF18-F18/120-J2024-04-12
06934415011419ZKSKBF18-F18/160-J2024-04-12
06934415011426ZKSKBF18-F18/180-J2024-04-12
06934415011433ZKSKBF18-F18/230-J2024-04-12
06934415011440ZKSKBF18-F18/50P-J2024-04-12
06934415011457ZKSKBF18-F18/120P-J2024-04-12
06934415011464ZKSKBF18-F18/160P-J2024-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18809327353290ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353313ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353320ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355515ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355805ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
06934415022309ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022316ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022323ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022347ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022354ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022125ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022149ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022156ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022163ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022170ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022187ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022194ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022279ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022286ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022293ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
16932503548325MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548332MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548349MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548356MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548363MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548370MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
04547410470420FUJIFILMFUJIFILM CORPORATIONKGE2022-03-04
04547410470437FUJIFILMFUJIFILM CORPORATIONKGE2022-03-04
14547410470441FUJIFILMFUJIFILM CORPORATIONKGE2022-03-04
14547410470458FUJIFILMFUJIFILM CORPORATIONKGE2022-03-04