FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10886982065414
·
Model: 03.000.195S
·
SYNTHES (U.S.A.) LP
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10886982065414
- Version / Model
- 03.000.195S
- Catalog Number
- 03000195S
- Company Name
- SYNTHES (U.S.A.) LP
- Labeler DUNS
- 832637081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 754e41f7-797b-4c40-9d36-156b8d57349f
Device Description
BURR CIRCULAR LENGTH 28MM Ø 12.0MM W/MINI QUICK COUPLING
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
- No
- 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 |
|---|---|---|---|---|
| DZI | DRILL, BONE, POWERED | Dental | 872.4120 | 2 |
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | Ear, Nose, Throat | 874.4250 | 2 |
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | General, Plastic Surgery | 878.4820 | 1 |
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | Neurology | 882.4310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36249 | Orthopaedic bur, reusable | A 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H67903000195S0 | HIBCC | ||||
| Primary | 10886982065414 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043310 | 000 |