DEVICE: Getinge Sterilization Indicator Tape 1" (00081443402034)

Device Identifier (DI) Information

Getinge Sterilization Indicator Tape 1"
61301600034
In Commercial Distribution
61301600034
STERITEC PRODUCT MFG. CO., INC.
00081443402034
GS1

1
622223196 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
No
No
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No
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 tape A non-sterile, flexible, band (typically made of paper) coated on one side with a pressure-sensitive adhesive, used to seal packages of instruments, utensils, or medical devices that are wrapped in drapes or sterilization packaging, prior to being sterilized in the hospital or other facility. This device will typically have indicators on its non-adhesive side that darken to indicate that the package has been sterilized. It typically comes in rolls in a variety of widths. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
JOJ Indicator, Physical/Chemical Sterilization Process
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 10 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 38 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

10567f9a-7822-4812-bf9f-fbfb91a1e89a
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10814434020346 36 00081443402034 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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