FDA UDI
In Commercial Distribution
🇺🇸 United States
VERIFY
DI: 10724995021396
·
Model: 802510
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
250
Basic Information
- Brand Name
- VERIFY
- Primary DI
- 10724995021396
- Version / Model
- 802510
- Catalog Number
- 802510
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 961394798
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 5
- Public Version Date
- 2020-11-03
- Public Version Status
- Update
- Public Device Record Key
- 6c38c20a-732d-40c0-941a-6425d51f8285
Device Description
The VERIFY Steam Sterilizer Load Record Cards, document load contents and confirm the load has been processed. They contain a chemical integrator for steam sterilization.
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 |
|---|---|---|---|---|
| FRC | Indicator, biological sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13732 | Biological sterilization indicator | A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10724995021396 | GS1 | ||||
| Unit of Use | 00724995021399 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from sterilizers
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid Sterilant or Cleaning Chemicals
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature.