FDA UDI
In Commercial Distribution
🇺🇸 United States
Bur PM2-70 80K Diam Ø2.7 St
DI: 17630055503371
·
Model: 1100371
·
Bien-Air Surgery SA
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bur PM2-70 80K Diam Ø2.7 St
- Primary DI
- 17630055503371
- Version / Model
- 1100371
- Catalog Number
- 1100371-001
- Company Name
- Bien-Air Surgery SA
- Labeler DUNS
- 481597719
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-08
- Public Version
- 2
- Public Version Date
- 2023-02-24
- Public Version Status
- Update
- Public Device Record Key
- 2e5fc041-0c6a-4be4-9368-4dd26246f533
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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | 882.4310 | 2 |
| HBC | Motor, Drill, Electric | Neurology | 882.4360 | 2 |
| NLY | Microdebrider, Ent, High Speed, Single Use, Reprocessed | Ear, Nose, Throat | 874.4140 | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | 874.4250 | 2 |
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | 874.4140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45527 | Diamond ENT bur, single-use | A rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17630055503371 | GS1 | ||||
| Previous | J00711003710011 | HIBCC |