FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOSTAP Control Unit
DI: 17630055505641
·
Model: 1600686
·
Bien-Air Surgery SA
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OSSEOSTAP Control Unit
- Primary DI
- 17630055505641
- Version / Model
- 1600686
- Catalog Number
- 1600686-001
- Company Name
- Bien-Air Surgery SA
- Labeler DUNS
- 481597719
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-09
- Public Version
- 1
- Public Version Date
- 2023-02-17
- Public Version Status
- New
- Public Device Record Key
- 74d17055-f714-4a01-b79c-74c3819f0bbe
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | 874.4250 | 2 |
| NLY | Microdebrider, Ent, High Speed, Single Use, Reprocessed | Ear, Nose, Throat | 874.4140 | 1 |
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | 874.4140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41264 | Surgical power tool system control unit, line-powered | A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17630055505641 | GS1 | ||||
| Previous | J00716006860011 | HIBCC |