FDA UDI
In Commercial Distribution
🇺🇸 United States
Cochlear™ Surgical Processor CP1150S
DI: 09321502046367
·
Model: P1648881
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cochlear™ Surgical Processor CP1150S
- Primary DI
- 09321502046367
- Version / Model
- P1648881
- Catalog Number
- P1648881
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-08
- Public Version
- 5
- Public Version Date
- 2024-07-22
- Public Version Status
- Update
- Public Device Record Key
- 19b7f3ae-03d8-4c01-abc5-fc5acfe8d6e8
Device Description
N/A
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MCM | Implant, cochlear | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64984 | Cochlear implant intraoperative electrophysiological transceiver | A noninvasive, electrically-powered device designed to wirelessly receive electrophysiological data (e.g., impedance, neural response) from the electrode array assembly of a cochlear implant system during implantation, and wirelessly transmit the data in real-time to an off-the-shelf computer/tablet with appropriate software installed. The data is intended for intraoperative analysis of the placement and in situ function of the implanted electrode array. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502046367 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970051 | 193 |