FDA UDI
In Commercial Distribution
🇺🇸 United States
iFIX
DI: 29010279000033
·
Model: Patch 15
·
iSYS Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- iFIX
- Primary DI
- 29010279000033
- Version / Model
- Patch 15
- Catalog Number
- 16180L001
- Company Name
- iSYS Medizintechnik GmbH
- Labeler DUNS
- 300207996
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2019-03-31
- Public Version
- 2
- Public Version Date
- 2020-11-19
- Public Version Status
- Update
- Public Device Record Key
- a1ee7a99-a757-40fc-85f3-c2e72a8e8fb4
Device Description
short-term patient stabilization device
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
- MR Safe
- Direct Marking Exempt
- Yes
- 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 | 49010279000037 | GS1 | Cardboard box | 4 | In Commercial Distribution | |
| Primary | 29010279000033 | GS1 | ||||
| Unit of Use | 09010279000039 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Millimeter | |
| Width | 100 | Millimeter |