FDA UDI
In Commercial Distribution
🇺🇸 United States
MR8
DI: 00763000865641
·
Model: MR8-23TD3010
·
MEDTRONIC ABLATION FRONTIERS, LLC
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MR8
- Primary DI
- 00763000865641
- Version / Model
- MR8-23TD3010
- Company Name
- MEDTRONIC ABLATION FRONTIERS, LLC
- Labeler DUNS
- 159933634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-01
- Public Version
- 1
- Public Version Date
- 2023-12-11
- Public Version Status
- New
- Public Device Record Key
- 51ed4058-77e8-49c3-85bd-369dcd1301de
Device Description
TOOL MR8-23TD3010 MR8 23CM TWSTDRL3X10MM
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HBC | MOTOR, DRILL, ELECTRIC | Neurology | 882.4360 | 2 |
| HSZ | Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment | General, Plastic Surgery | 878.4820 | 1 |
| HBB | MOTOR, DRILL, PNEUMATIC | Neurology | 882.4370 | 2 |
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | Neurology | 882.4310 | 2 |
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | Ear, Nose, Throat | 874.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45553 | Orthopaedic bur, single-use | A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000865641 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183515 | 000 |