DEVICE: Sterrad (10705037016198)

Device Identifier (DI) Information

Sterrad
14100
In Commercial Distribution
14100
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
10705037016198
GS1

250
947451626 *Terms of Use
Chemical Indicator Strip
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JOJ Indicator, physical/chemical sterilization process
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K103218 000
K111518 000
K921910 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Wrap processed indicator in a plastic bag. Do not cover processed Indicator with transparent tape.
Special Storage Condition, Specify: Store in a dry area away from sources of light, and acids, bases and STERRAD sterilizer both before and after sterilization. Avoid direct contact with paper or cardboard.
Storage Environment Temperature: between 15 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

2c5d32b4-1202-48ab-b469-9856b04f1c08
July 06, 2018
3
September 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20705037016195 4 10705037016198 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 80705037016197 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(888)783-7723
complaints@aspus.jnj.com
CLOSE