FDA UDI
In Commercial Distribution
🇺🇸 United States
neXus
DI: 00841626103016
·
Model: 110-31-1230
·
MISONIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- neXus
- Primary DI
- 00841626103016
- Version / Model
- 110-31-1230
- Company Name
- MISONIX, INC.
- Labeler DUNS
- 065963449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-24
- Public Version
- 1
- Public Version Date
- 2020-03-03
- Public Version Status
- New
- Public Device Record Key
- 184036a3-640d-4917-a87a-5eba4d36cf52
Device Description
neXus BoneScalpel® Diamond Shaver & Tubeset
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60718 | Hard-tissue ultrasonic surgical system handpiece tip | A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00841626103313 | GS1 | box | 5 | In Commercial Distribution | |
| Primary | 00841626103016 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190160 | 000 |