FDA UDI
In Commercial Distribution
🇺🇸 United States
BurSafe Bur Holder- Clean Green
DI: 00723896006146
·
Model: 53C9060
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Basic Information
- Brand Name
- BurSafe Bur Holder- Clean Green
- Primary DI
- 00723896006146
- Version / Model
- 53C9060
- Catalog Number
- 70-39730-GRE
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2019-10-10
- Public Version
- 2
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 062101ea-c86b-4d72-8f18-277fcf9187fd
Device Description
Bur storage, sterilization and retrieval easier and safer than ever. Unique design stores six burs horizontally, and removal is as simple as pressing down on one end. Two models accommodate both FG and RA burs and slide easily into small, flat sterilization pouches.Fully Sterilizable to 375 degrees F
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 62851 | Surgical instrument interim-placement holder, reusable | A device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896006184 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 00723896006146 | GS1 | ||||
| Unit of Use | 00723896005330 | GS1 |