FDA.reportPublic FDA data

ZKSK

Primary DI
06934415023061
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
HE15-195-2
Device description
Disposable Ligation Device
Published
2023-12-28
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
MNDLigator, Esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNDLigator, EsophagealGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934415023061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415023061069344150230616934415023061

GMDN Terms#

Term, Definition table
TermDefinition
Polypectomy endoscopic ligator, single-useA device used in combination with a compatible flexible endoscope for the deployment of a ligature loop (a self-locking device made of, e.g., a polymer in the form of a thin band) that is typically applied to large colorectal or pedunculated polyps in the gastrointestinal (GI) tract to prevent or control bleeding following polypectomy. It typically consists of an insertion sheath, the ligature loop at the distal end, and a control handle at the proximal end used to deploy the loop. This device may be used to ligate the appendix during its removal. 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
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
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
16934415066621ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066638ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066645ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066652ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066669ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066676ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
14953170462396Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
14953170462426Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
14953170462488Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
14953170462549Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
06934415023191ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023207ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023214ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023221ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023115ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023122ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023139ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023146ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023153ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023160ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023177ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023184ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023023ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023030ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023047ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023054ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023078ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023085ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023092ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023108ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28