DEVICE: Sterrad SealSure (10705037016204)

Device Identifier (DI) Information

Sterrad SealSure
14202
In Commercial Distribution
14202
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
10705037016204
GS1

1
947451626 *Terms of Use
Chemical Indicator Tape
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 [?]
K040742 000
K111519 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: dissolve the chemical indicatorBefore and after processing, store away from sterilizer or sources of ethylene oxidehydrogen peroxide and strongacidsDonot spill solvents such as IPA orAcetoneonthetape
Special Storage Condition, Specify: Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids. Do not spill solvents such as IPA or Acetone on the tape as the solventsmay
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

3877ba77-8f26-42bc-91f6-9bb31eec0a29
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
20705037016201 6 10705037016204 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: No Unit of Use DI Numbers Found 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