FDA UDI
In Commercial Distribution
🇺🇸 United States
FENTEX
DI: 04250407733100
·
Model: 411200FX
·
FENTEX medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FENTEX
- Primary DI
- 04250407733100
- Version / Model
- 411200FX
- Catalog Number
- 411200FX
- Company Name
- FENTEX medical GmbH
- Labeler DUNS
- 507221724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-12
- Public Version
- 1
- Public Version Date
- 2022-12-20
- Public Version Status
- New
- Public Device Record Key
- f2426b10-b92a-479a-99b6-9ecb9ebd968e
Device Description
Gouge by West 18 cm, width 4 mm
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
- 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
- No
- 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 |
|---|---|---|---|---|
| 35914 | Nasal gouge | A single-bladed, hand-held manual surgical instrument designed to cut and shape the bone and cartilage of the nose during ear/nose/throat (ENT) surgery. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is typically made of high-grade stainless steel as a one-piece instrument and is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250407733100 | GS1 |
Customer Contacts
- Phone
- +4974679496212
- [email protected]