FDA UDI
Not in Commercial Distribution
🇺🇸 United States
X-Trans™ 24" Double Armboard
DI: 10841962109649
·
Model: 8002067
·
Qfix
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- X-Trans™ 24" Double Armboard
- Primary DI
- 10841962109649
- Version / Model
- 8002067
- Catalog Number
- 8002067
- Company Name
- Qfix
- Labeler DUNS
- 808875397
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-22
- Public Version
- 4
- Public Version Date
- 2023-12-11
- Public Version Status
- Update
- Public Device Record Key
- 4ff92ca4-695c-4db6-8757-66c8d5acef89
- Distribution End Date
- 2017-03-16
Device Description
X-Trans Armboards 24” Double Armboard
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
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDC | TABLE, OPERATING-ROOM, ELECTRICAL | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40900 | Radiological arm/leg positioner | A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841962109649 | GS1 |
Customer Contacts
- Phone
- +1(610)268-0585
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Fits 24" table | ||
| Width | 24 | Inch |