FDA UDI
In Commercial Distribution
🇺🇸 United States
Insertion Electrode FLEX34
DI: 09008737416218
·
Model: 41621
·
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
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
- Insertion Electrode FLEX34
- Primary DI
- 09008737416218
- Version / Model
- 41621
- Company Name
- Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Labeler DUNS
- 300764032
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-15
- Public Version
- 3
- Public Version Date
- 2026-03-23
- Public Version Status
- Update
- Public Device Record Key
- c8e16333-5502-4641-b5bc-81fc19f6cc56
Device Description
Insertion Electrode
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MCM | Implant, Cochlear | Unknown | 3 |
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 | 09008737416218 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000025 | 127 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the sterilized contents in this box at room temperature until the stated expiry date.