FDA.reportPublic FDA data

ZKSK

Primary DI
06934415045001
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
GW18-25-450
Device description
Disposable Guide Wire
Published
2023-12-26
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
OCYEndoscopic Guidewire, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCYEndoscopic Guidewire, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934415045001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415045001069344150450016934415045001

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. 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
04262494460616N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460623N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460630N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460647N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494462528N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494463969N/ADoppkon GmbH & Co. KGOCY2025-09-12
54953170465050VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465067VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465074VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465081VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465098VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465104VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465111VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465128VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465135VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465142VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465159VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465166VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465173VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465180VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465197VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465203VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
05708932767781SopranoColoplast A/SOCY2025-03-26
16932503510131Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510148Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510155Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510162Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16976055232974Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24
16976055232981Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24
16976055232998Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24