AccessGUDID - DEVICE: Sterrad SealSure (10705037016204)

GUDID

Device Identifier (DI) Information

Brand Name: Sterrad SealSure
Version or Model: 14202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14202
Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Primary DI Number: 10705037016204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 947451626 *Terms of Use

Device Description: Chemical Indicator Tape

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, physical/chemical sterilization process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040742	000
K111519	000

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

[?]

Storage and Handling
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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3877ba77-8f26-42bc-91f6-9bb31eec0a29
Public Version Date: February 21, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2016