DEVICE: Sterling Washers (10841736110741)
Device Identifier (DI) Information
Sterling Washers
P1500-FLX-KB
In Commercial Distribution
P1500-FLX-KB
SKYTRON LLC
P1500-FLX-KB
In Commercial Distribution
P1500-FLX-KB
SKYTRON LLC
Shelf level set for up to 18 kidney bowls, use w/ P1500-B4L, FLX2 or FLX4
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
66797 | 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MEC | Disinfector, medical devices |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 0 and 80 Percent (%) Relative Humidity |
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 70 Degrees Celsius |
Handling Environment Temperature: between -20 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
74eadbfc-4002-4811-be9d-dff24f6c49f2
October 04, 2023
3
November 22, 2016
October 04, 2023
3
November 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)759-8766
info@skytron.us
info@skytron.us