FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10724995221970
·
Model: 260010
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
9
Basic Information
- Brand Name
- NA
- Primary DI
- 10724995221970
- Version / Model
- 260010
- Catalog Number
- 260010
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 868205779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 9
- Record Status
- Published
- Publish Date
- 2023-02-17
- Public Version
- 1
- Public Version Date
- 2023-02-27
- Public Version Status
- New
- Public Device Record Key
- 5af40c8f-dfe3-4fa9-9e2e-ff64684762fd
Device Description
The VERIFY STEAM Indicator Tape adheres to both natural and synthetic materials commonly used in sterile processing and its color-changing indicator stripes provides immediate identification that items were exposed to a steam cycle.
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
- No
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00724995221973 | GS1 | ||||
| Primary | 10724995221970 | GS1 | ||||
| Previous | 10724995184916 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Yard | |
| Width | 1 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Controlled Room Temperature