FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00724995151379
·
Model: FD82000
·
Corporation Steris Canada
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00724995151379
- Version / Model
- FD82000
- Catalog Number
- FD82000
- Company Name
- Corporation Steris Canada
- Labeler DUNS
- 202659140
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 4
- Public Version Date
- 2021-01-28
- Public Version Status
- Update
- Public Device Record Key
- d626628c-cd16-4ec7-bd7c-7d4637afb059
Device Description
The Rack for Five Sterile Goods Container for use with The Vision Single Chamber Washer Disinfector and AMSCO 7053L Washer Disinfector.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEC | Disinfector, medical devices | General Hospital | 880.6992 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62151 | Sterilizer/disinfector rack | A non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995151379 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]