FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSA® Excel
DI: 10381780026136
·
Model: C6636
·
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CUSA® Excel
- Primary DI
- 10381780026136
- Version / Model
- C6636
- Catalog Number
- C6636
- 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
- 8
- Public Version Date
- 2023-04-14
- Public Version Status
- Update
- Public Device Record Key
- a7b7246e-67c0-4bcc-95ec-14869125e77b
Device Description
CUSA® Excel 36 kHz CEM™ Nosecone
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 |
|---|---|---|---|---|
| 47547 | Ultrasonic surgical system adaptor, single-use | A small, sterile, connecting device designed to fit between the component devices of an ultrasonic surgical system (i.e., the handpiece tip, handpiece, and generator) to enable them to join each other. It may include controls (e.g., buttons) that allow the operator to activate different power level settings for the system during surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30381780026130 | GS1 | BOX | 6 | In Commercial Distribution | |
| Primary | 10381780026136 | GS1 | ||||
| Secondary | M269C66361 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 36 kHz 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.