FDA UDI
In Commercial Distribution
🇺🇸 United States
GAIT BELT DISP BLUE 70 IN PLASTIC BUCKLE CS 36
DI: 00733657230635
·
Model: 710135
·
ALIMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
36
Basic Information
- Brand Name
- GAIT BELT DISP BLUE 70 IN PLASTIC BUCKLE CS 36
- Primary DI
- 00733657230635
- Version / Model
- 710135
- Catalog Number
- 2970008478
- Company Name
- ALIMED, INC.
- Labeler DUNS
- 056007248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 3
- Public Version Date
- 2024-02-26
- Public Version Status
- Update
- Public Device Record Key
- 296ac0ee-e714-443a-ab5f-63a865311f26
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 |
|---|---|---|---|---|
| IKX | AID, TRANSFER | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63227 | Movement-resistance gait rehabilitation device | A collection of wearable belts, vest, straps and pulleys designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) with regaining lost motor function for ambulation using movement-resistant attachments to the legs/feet. This is a non-powered device intended to be used in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733657230635 | GS1 | ||||
| Unit of Use | 00733657299281 | GS1 |
Customer Contacts
- Phone
- +1(781)329-2900 ext. 0
- [email protected]