FDA UDI
In Commercial Distribution
🇺🇸 United States
Cochlear™ Nucleus® Contour Advance® Depth Gauge
DI: 09321502019439
·
Model: Z179994
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cochlear™ Nucleus® Contour Advance® Depth Gauge
- Primary DI
- 09321502019439
- Version / Model
- Z179994
- Catalog Number
- Z179994
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-21
- Public Version
- 3
- Public Version Date
- 2023-01-10
- Public Version Status
- Update
- Public Device Record Key
- 77848b20-e932-4078-a516-3b7610116825
Device Description
electrode depth gauge
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LRC | INSTRUMENT, ENT MANUAL SURGICAL | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61603 | Cochlear electrode array depth gauge, single-use | A hand-held manual surgical instrument intended to be used during insertion of an electrode array into the cochlea during implantation of a cochlear implant, to determine the number of active bands that can be implanted, to measure insertion depth, and sometimes to assess cochlear lumen patency. It consists of a thin probe with depth markings mounted on a handle, made of metal [e.g., platinum (Pt)] and synthetic polymers (e.g., silicone). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502019439 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 75 Percent (%) Relative Humidity