FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgical Claw 2
DI: 09008737367381
·
Model: 36738
·
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Surgical Claw 2
- Primary DI
- 09008737367381
- Version / Model
- 36738
- Catalog Number
- N/A
- 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
- 2025-12-17
- Public Version
- 1
- Public Version Date
- 2025-12-25
- Public Version Status
- New
- Public Device Record Key
- 2b81bc84-3ee1-45cc-8389-c5bb1991b2f1
Device Description
Reusable Surgical Tool
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 61446 | Cochlear electrode array introducer, reusable | A non-sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin probe with a clawed distal end mounted on a handle and is made of high-grade stainless steel. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09008737367381 | GS1 |