FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756805469
·
Model: 25-012
·
DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DeRoyal
- Primary DI
- 00749756805469
- Version / Model
- 25-012
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d2f81550-cfa1-4829-adb1-6bab5c8168ef
Device Description
Instrument Pad
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47824 | Surgical instrument magnetic mat | A sterile device designed as a small flexible drape (a mat) with a fluid-impervious surface (e.g., rubber/vinyl) and a non-sliding soft backing with embedded magnets intended to be used to attract and hold the surgical instruments that are placed upon it during a surgical procedure. It is typically used in an operating room (OR) or for general surgery and will help minimize the risk of percutaneous injuries to the operating staff whilst providing an effective method of keeping the instruments in place during transfer in the OR. It is available in various sizes. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50749756805464 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 00749756805469 | GS1 |
Customer Contacts
- Phone
- +1(888)938-7828
- [email protected]