AccessGUDID - DEVICE: Sterrad (10705037016532)

GUDID

Device Identifier (DI) Information

Brand Name: Sterrad
Version or Model: 20236
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20236
Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Primary DI Number: 10705037016532
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947451626 *Terms of Use

Device Description: Sterrad 50/100S Sterilizer Cyclesure 24 Validation Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Sterilization packaging, single-use	A device intended to be used to enclose 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.
Chemical/physical sterilization process indicator	A sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.
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).
Instrument tray	A flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems and sterilizers; it is not dedicated to sterilization. This device may or may not be fitted with a lid or cover. This is a reusable device.
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.

FDA Product Code

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Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 72c24423-22ed-4004-84cb-74e0d1c8598c
Public Version Date: May 08, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016