FDA.report

ZKSK

Primary DI
06934415087018
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
EP18-07
Device description
Disposable Pulse Lavage
Published
2024-04-09
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
FQHLavage, Jet

Product Code Classifications

CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06934415087018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06934415087018069344150870186934415087018

GMDN Terms

TermDefinition
Disposable surgical irrigation/aspiration systemA device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+8613260186661Barbie@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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