FDA UDI
In Commercial Distribution
🇺🇸 United States
Compact Steri-Container Neon Blue
DI: 00840161300904
·
Model: 50Z905N
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Compact Steri-Container Neon Blue
- Primary DI
- 00840161300904
- Version / Model
- 50Z905N
- Company Name
- ZIRC DENTAL PRODUCTS, INC.
- Labeler DUNS
- 064783913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-04
- Public Version
- 1
- Public Version Date
- 2022-10-12
- Public Version Status
- New
- Public Device Record Key
- 5d23476a-4a33-4946-b885-accdfb2a122b
Device Description
"Used to contain instruments during ultrasonic and sterilization procedures Durable, self-lubricating plastic with a securely snapping lid Dimensions: 7-1/8"" x 1-1/2"" x 1-1/2"" Contains Antimicrobial Protection Autoclavable up to 136°C/275F° 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
- Yes
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 |
|---|---|---|---|---|
| 42893 | General-purpose bowl, reusable | A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840161300904 | GS1 | ||||
| Previous | D68550Z905N0 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 181 | Millimeter | |
| Width | 38 | Millimeter | |
| Height | 38 | Millimeter |