FDA UDI
In Commercial Distribution
🇺🇸 United States
KIT ARMPAD FULL W/2 SCREWS CLR
DI: 00841447114949
·
Model: 8881127509
·
INVACARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KIT ARMPAD FULL W/2 SCREWS CLR
- Primary DI
- 00841447114949
- Version / Model
- 8881127509
- Company Name
- INVACARE CORPORATION
- Labeler DUNS
- 076916246
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-25
- Public Version
- 1
- Public Version Date
- 2024-08-02
- Public Version Status
- New
- Public Device Record Key
- 2a8c39ae-7e65-4941-8158-8d390ace94d1
Device Description
Arm Pad w/ screws, Full-Length (13")
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| IML | Armrest, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32981 | Wheelchair armrest | A small platform, typically cushioned, mounted on the lateral ends of a wheelchair to provide the user with a support on which to place the arms. The position of the platform (e.g., height) may be adjustable to suit the comfort and utility of the user. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841447114949 | GS1 |
Customer Contacts
- Phone
- +1(440)329-6000
- [email protected]