FDA UDI
In Commercial Distribution
🇺🇸 United States
Performance Tool Organizer Red
DI: 00840161301031
·
Model: 50Z940M
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Performance Tool Organizer Red
- Primary DI
- 00840161301031
- Version / Model
- 50Z940M
- Company Name
- ZIRC DENTAL PRODUCTS, INC.
- Labeler DUNS
- 064783913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-25
- Public Version
- 1
- Public Version Date
- 2022-11-02
- Public Version Status
- New
- Public Device Record Key
- 44fdc8d0-f611-4db6-bac2-e52887f4cb75
Device Description
"Ideal for Large Specialty Instruments Customizable, removable feet Superior water flow for superb cleaning Compact styling to fit most sterilizers Attached cover that rolls back easily Dimensions: 8-3/16” x 4-1/4” x 1-7/32” Autoclavable up to 136°C/277F°"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16349 | Instrument transport trolley system | A combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840161301031 | GS1 | ||||
| Previous | D68550Z940M0 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 211 | Millimeter | |
| Width | 108 | Millimeter | |
| Height | 32 | Millimeter |