FDA.report

ZKSK

Primary DI
06934415044530
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
GW18-35-450S
Device description
Disposable Guide Wire
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

Related Records

Contact Domains

Product Codes

CodeName
OCYEndoscopic Guidewire, Gastroenterology-Urology

Product Code Classifications

CodeDeviceSpecialtyClass
OCYEndoscopic Guidewire, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06934415044530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06934415044530069344150445306934415044530

GMDN Terms

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

Contacts

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 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

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