DEVICE: Sterrad (10705037016532)
Device Identifier (DI) Information
Sterrad
20236
Not in Commercial Distribution
20236
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
20236
Not in Commercial Distribution
20236
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Sterrad 50/100S Sterilizer Cyclesure 24 Validation Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
13735 | Sterilization packaging, single-use |
A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.
|
Active | false |
35362 | Chemical/physical sterilization process indicator |
A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.
|
Active | false |
35482 | Aerobic laboratory incubator |
A mains electricity (AC-powered) device heated by electrical currents passing through a heating block containing simple resistors (usually coils of nickel-chromium wire) for the purpose of growing microorganisms and cells that require oxygen (O2) for growth. Aerobic incubators are typically used for serology and crystallization studies, tissue culture work, paraffin wax embedding and in vitro fertilization (IVF).
|
Active | false |
12143 | Instrument tray, reusable |
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
|
Active | false |
13732 | Biological sterilization indicator |
A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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No Product Codes |
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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Special Storage Condition, Specify: Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde, |
Special Storage Condition, Specify: STERRAD™ cassettes, or any other oxidizers. |
Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
72c24423-22ed-4004-84cb-74e0d1c8598c
May 26, 2025
14
September 24, 2016
May 26, 2025
14
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 |
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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(888)783-7723
ASP-Complaints@asp.com
ASP-Complaints@asp.com