FDA.report

Flex Surgical Instrument Washer

Primary DI
10841736111663
Brand
Flex Surgical Instrument Washer
Company
SKYTRON LLC
Model
CS-0040-000
Catalog number
CS-0040-000
Device description
Flex Surgical Instrument Washer
Published
2018-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MECDisinfector, medical devices

Product Code Classifications

CodeDeviceSpecialtyClass
MECDisinfector, Medical DevicesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841736111663PrimaryGS10

GMDN Terms

TermDefinition
Surgical instrument washer/disinfector (chemical/thermal)An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)759-8766info@skytron.us

Regulatory Flags

DUNS number
078375583
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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