DEVICE: Sterrad (10705037015184)
Device Identifier (DI) Information
Sterrad
10207
Not in Commercial Distribution
10207
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
10207
Not in Commercial Distribution
10207
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Shelf Sterrad 200 2-Tier
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
40596 | Electromechanical device/system transport trolley |
A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MLR | Sterilizer, chemical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K042116 | 000 |
K142454 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 18 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a8387a97-dfab-4670-96d0-46f67c1dbc07
June 22, 2023
6
September 24, 2016
June 22, 2023
6
September 24, 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 |
---|---|
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(888)783-7723
ASP-Complaints@asp.com
ASP-Complaints@asp.com