FDA UDI
In Commercial Distribution
🇺🇸 United States
Assist Stand
DI: 00840161302137
·
Model: 50Z462
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Assist Stand
- Primary DI
- 00840161302137
- Version / Model
- 50Z462
- Company Name
- ZIRC DENTAL PRODUCTS, INC.
- Labeler DUNS
- 064783913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-05
- Public Version
- 1
- Public Version Date
- 2022-10-13
- Public Version Status
- New
- Public Device Record Key
- 4e880741-311d-44a0-b17b-4743c82e0c43
Device Description
"Dense foam cleans bio-debris easier and faster and holds Endo instruments in an upright position Square shape fits great in procedure tub Thicker foam prevents solution from leaking - has rounded corners for easy cleaning Available in black only Dimensions: 1-7/8"" x 1-7/8"" x 1-1/4"" Autoclavable up to 136°C/275°F 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 |
|---|---|---|---|---|
| 34004 | Surgical instrument guard, reusable | A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840161302137 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 46.6 | Millimeter | |
| Width | 46.6 | Millimeter | |
| Height | 31.8 | Millimeter |