FDA UDI
In Commercial Distribution
🇺🇸 United States
Ocelot
DI: 00860008843500
·
Model: DU1F60L
·
Tendonova Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ocelot
- Primary DI
- 00860008843500
- Version / Model
- DU1F60L
- 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
- 18ca24da-8a42-4edd-bdca-7e15ff3107d4
Device Description
TendoNova Ocelot DU1F60L Disposable Unit- 60mm
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
- No
- 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 |
|---|---|---|---|---|
| LFL | Instrument, ultrasonic surgical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44755 | Soft-tissue ultrasonic surgical system handpiece tip, single-use | A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10860008843507 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 00860008843500 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212049 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius