FDA UDI
In Commercial Distribution
🇺🇸 United States
Cochlear™ Sterile Non-Magnetic Plug
DI: 09321502046527
·
Model: P1620901
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Cochlear™ Sterile Non-Magnetic Plug
- Primary DI
- 09321502046527
- Version / Model
- P1620901
- Catalog Number
- P1620901
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-09
- Public Version
- 1
- Public Version Date
- 2021-03-17
- Public Version Status
- New
- Public Device Record Key
- ca480776-efba-4663-af08-35e6cd021030
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
- MR Conditional
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PFO | Active implantable bone conduction hearing system | Ear, Nose, Throat | 874.3340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62602 | Cochlear implant dummy magnet | A small sterile device intended to be implanted short term as a temporary replacement for a cochlear implant magnet during a magnetic resonance imaging (MRI) scan. It is typically in the same form as a cochlear implant magnet but without any magnetic material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502046527 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191921 | 000 |