FDA UDI
In Commercial Distribution
🇺🇸 United States
Bur OSSEOSTAP Diam Ø2.3 mm St
DI: 17630055504682
·
Model: 1501236
·
Bien-Air Surgery SA
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bur OSSEOSTAP Diam Ø2.3 mm St
- Primary DI
- 17630055504682
- Version / Model
- 1501236
- Catalog Number
- 1501236-001
- Company Name
- Bien-Air Surgery SA
- Labeler DUNS
- 481597719
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-27
- Public Version
- 6
- Public Version Date
- 2023-02-28
- Public Version Status
- Update
- Public Device Record Key
- 4f5b4e02-8f06-4a3a-9f7f-f49673efea84
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 |
|---|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | 874.4140 | 1 |
| 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11339 | Middle ear drill bit | A cylindrical shaft of metal with a small cutting head (e.g., twisted or helicoidal) which when rotated will bore into the tissues of the middle ear to excavate, perforate, or excise tissue (e.g., ossicles, cartilage) during a middle ear (endaural) surgical procedure. This device is typically mounted into a powered surgical drill system handpiece that provides rotation. It is available in various cutting head sizes/shapes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 27630055504689 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 17630055504682 | GS1 |