FDA UDI
In Commercial Distribution
🇺🇸 United States
E-Z Jett Cassette 10-Place Gray
DI: 00840161300522
·
Model: 50Z930I
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- E-Z Jett Cassette 10-Place Gray
- Primary DI
- 00840161300522
- Version / Model
- 50Z930I
- 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
- 7b7aad93-c54d-49a5-9c68-8efff4db99cc
Device Description
"Holds 10 instruments Compartment in the middle to hold more instruments Open top, rounded holes and corners allow for superior water flow compared to normal cassettes Covers are attached to the cassette and open and fold back easily Dimensions: 7-15/16"" x 7"" x 1-1/8"" Contains Antimicrobial Protection Autoclavable up to 136°C/277F° Washer-disinfect"
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 | 00840161300522 | GS1 | ||||
| Previous | D68550Z930I0 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 202 | Micrometer | |
| Width | 178 | Millimeter | |
| Height | 29 | Millimeter |