FDA UDI
In Commercial Distribution
🇺🇸 United States
iFIX
DI: 09010279001708
·
Model: iFIX Side Rail Adapter US
·
iSYS Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- iFIX
- Primary DI
- 09010279001708
- Version / Model
- iFIX Side Rail Adapter US
- Catalog Number
- 42642-US
- Company Name
- iSYS Medizintechnik GmbH
- Labeler DUNS
- 300207996
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-30
- Public Version
- 1
- Public Version Date
- 2024-08-07
- Public Version Status
- New
- Public Device Record Key
- 083edf86-b107-4da2-a1b7-862e5f385818
Device Description
Designed for connection with operating tables, contains a side-rail adapter portion (to fit US side-rails) and a flat plastic portion to which a standard iFIX Patch with custom size is attached. Ideal for interventions and surgery, where tables often exhibit a side-rail at different patient heights and allow a strong and clean fixation of equipment, including the iFIX Side-Rail Adapter.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMQ | Restraint, Protective | General Hospital | 880.6760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63966 | Medical table restraint anchor | A device intended to be fixed to an operating/radiological table to provide a firmly secure point of attachment for a non-rigid restraint (e.g., strap, band, fabric sheet) to help achieve patient positioning and stabilization during a medical procedure. It may be in the form of a piece of flat material with double-sided adhesive, or a rigid sliding pad/plate that is attached to or fits into a matching slot on the medical table or table rails. Disposable positioners/restraints may be included with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 29010279001702 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 09010279001708 | GS1 |