FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterrad SealSure
DI: 10705037016204
·
Model: 14202
·
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sterrad SealSure
- Primary DI
- 10705037016204
- Version / Model
- 14202
- Catalog Number
- 14202
- Company Name
- ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Labeler DUNS
- 947451626
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- 3877ba77-8f26-42bc-91f6-9bb31eec0a29
Device Description
Chemical Indicator Tape
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOJ | Indicator, physical/chemical sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705037016201 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 10705037016204 | GS1 |
Customer Contacts
- Phone
- +1(888)783-7723
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius