FDA UDI
In Commercial Distribution
🇺🇸 United States
ALIMED HIPSHIELD XTRA, 4 PANTS, 1 SET OF PADS
DI: 00733657263930
·
Model: 713287/NA/NA/XL
·
ALIMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ALIMED HIPSHIELD XTRA, 4 PANTS, 1 SET OF PADS
- Primary DI
- 00733657263930
- Version / Model
- 713287/NA/NA/XL
- Catalog Number
- 2970009224
- Company Name
- ALIMED, INC.
- Labeler DUNS
- 056007248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 2585647f-931e-4a07-a9d0-95da5942a33c
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| IQI | ORTHOSIS, LIMB BRACE | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36312 | Hip protection trousers | A garment intended to be worn over a patient?s hips to provide protection for the protruding hip areas (greater trochanter) and against the possibility of a hip (neck of femur) or femoral shaft fracture in the event of a patient fall. This device is typically available as an undergarment or outer trousers designed with built-in pads or specialized side pockets for the placement of removable firm pads (one on either side) that transfer the energy from the impact of a fall to the soft tissue and muscles anterior and posterior to the femoral bone, thus diverting the force of the impact away from the greater trochanter. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733657263930 | GS1 |
Customer Contacts
- Phone
- +1(781)329-2900 ext. 0
- [email protected]