FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 10724995184916
·
Model: 260010
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
9
Basic Information
- Brand Name
- NA
- Primary DI
- 10724995184916
- Version / Model
- 260010
- Catalog Number
- 260010
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 961394798
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 9
- Record Status
- Published
- Publish Date
- 2019-11-15
- Public Version
- 5
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 6d68f3e5-bb4e-493b-96f7-2b879d47d14e
- Distribution End Date
- 2023-02-17
Device Description
The VERIFY General Purpose Steam Process Indicator Tape adheres to both natural and synthetic materials commonly used in sterile processing. They are used to identify processed packs from unprocessed packs.
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 |
|---|---|---|---|---|---|---|
| Previous | 10724995044067 | GS1 | ||||
| Primary | 10724995184916 | GS1 | ||||
| Unit of Use | 00724995184919 | 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
- Special Storage Condition, Specify
- Special Conditions
- Controlled Room Temperature
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius