FDA UDI
In Commercial Distribution
🇺🇸 United States
FISSO
DI: 07640152572791
·
Model: 3840.98
·
Baitella AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FISSO
- Primary DI
- 07640152572791
- Version / Model
- 3840.98
- Company Name
- Baitella AG
- Labeler DUNS
- 484942081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-30
- Public Version
- 2
- Public Version Date
- 2023-02-01
- Public Version Status
- Update
- Public Device Record Key
- fa06ef42-3f49-43ee-b029-76773c69ff70
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
- 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 |
|---|---|---|---|---|
| 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 | 07640152572791 | GS1 |
Customer Contacts
- Phone
- +41443058000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length (action radius of articulated arm): 400 mm, Column: 400 mm |