FDA UDI
In Commercial Distribution
🇺🇸 United States
FENTEX
DI: 04250407786670
·
Model: 118970FX
·
FENTEX medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FENTEX
- Primary DI
- 04250407786670
- Version / Model
- 118970FX
- Catalog Number
- 118970FX
- Company Name
- FENTEX medical GmbH
- Labeler DUNS
- 507221724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-28
- Public Version
- 1
- Public Version Date
- 2025-01-06
- Public Version Status
- New
- Public Device Record Key
- 1562fb0f-b85f-4c61-b96f-4fae846b838a
Device Description
Articulated arm with L-Column, with central one hand fixation, 40 cm
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 |
|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62379 | Surgical instrument assist arm system, manually-adjusted | A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250407786670 | GS1 |
Customer Contacts
- Phone
- +4974679496212
- [email protected]