FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgical handpiece 1:1
DI: ENOU1950NOU0
·
Model: 1950nou
·
Nouvag AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Surgical handpiece 1:1
- Primary DI
- ENOU1950NOU0
- Version / Model
- 1950nou
- Company Name
- Nouvag AG
- Labeler DUNS
- 480610476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-27
- Public Version
- 5
- Public Version Date
- 2018-11-22
- Public Version Status
- Update
- Public Device Record Key
- b72afb33-2008-48bd-b833-10e3ca22b314
Device Description
Surgical handpiece straight 70mm
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
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | 874.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37867 | Surgical power tool system handpiece, rotary, rechargeable battery-powered | A hand-held device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drill bits, reamers, cutters) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. It is powered by an attached rechargeable battery pack to directly provide low-voltage electricity to the motor of the handpiece. The device may be cannulated to allow the use of a guidewire. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ENOU1950NOU0 | HIBCC |
Customer Contacts
- Phone
- +41718466600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042434 | 000 |