FDA UDI
In Commercial Distribution
🇺🇸 United States
De Soutter Medical
DI: 05051471152540
·
Model: R60-201
·
DE SOUTTER MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- De Soutter Medical
- Primary DI
- 05051471152540
- Version / Model
- R60-201
- Catalog Number
- R60-201
- Company Name
- DE SOUTTER MEDICAL LIMITED
- Labeler DUNS
- 458064144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 2
- Public Version Date
- 2023-06-27
- Public Version Status
- Update
- Public Device Record Key
- 3302e194-d5e5-4fc1-bd12-ffe1127a87de
Device Description
BUR - DISC CUTTER DIAMOND 25.4mm DIA x 62mm
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64295 | Metal-cutting bur | A rotary cutting device consisting of a shaft and a cutting working end made of hard materials (e.g., high-grade steel, carbide, diamond) which is designed to fit into an appropriate powered handpiece that provides the rotation, and is intended for cutting hard metal, typically a device/implant during orthopaedic surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15051471152547 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 05051471152540 | GS1 |