FDA UDI
In Commercial Distribution
🇺🇸 United States
Ocelot
DI: 00860008843517
·
Model: RDU-1000
·
Tendonova Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ocelot
- Primary DI
- 00860008843517
- Version / Model
- RDU-1000
- Company Name
- Tendonova Corporation
- Labeler DUNS
- 115587907
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-07
- Public Version
- 1
- Public Version Date
- 2023-03-15
- Public Version Status
- New
- Public Device Record Key
- 37f61227-7b76-41d6-9c1e-8c01918cd5e5
Device Description
RDU 1000 TendoNova Ocelot Nano Reusable Drive Unit
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
- 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 |
|---|---|---|---|---|
| 44750 | Soft-tissue ultrasonic surgical system handpiece, reusable | A hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end to mechanically fragment soft-tissue cells upon contact for cutting and/or coagulating tissue during surgery. The handpiece may also serve as a conduit for irrigation and aspiration during surgery. It is typically in the form of a pen/pencil or elongated probe with permanently attached cables. This is a non-dedicated device intended to be used in multiple clinical specialties. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008843517 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212049 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius