FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSA® Excel MacroTip™
DI: 10381780025955
·
Model: C4605S
·
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CUSA® Excel MacroTip™
- Primary DI
- 10381780025955
- Version / Model
- C4605S
- Catalog Number
- C4605S
- Company Name
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Labeler DUNS
- 989925396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-29
- Public Version
- 7
- Public Version Date
- 2023-05-16
- Public Version Status
- Update
- Public Device Record Key
- da891c62-81b7-4d18-8f5a-866b001e291c
Device Description
CUSA® Excel 23kHz 2.64mm MacroTip™ Tip
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
- 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 | |
| LBK | Device, neurosurgical fragmentation and aspiration | 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 | 30381780025959 | GS1 | BOX | 4 | In Commercial Distribution | |
| Primary | 10381780025955 | GS1 | ||||
| Secondary | M269C4605S17 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2.64mm ID x 7.95cm length; 3.84g weight; 23kHz frequency |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature -34°C to 65°C; Relative Humidity 25% to 85%, non-condensing; Keep Dry.