FDA UDI
In Commercial Distribution
🇺🇸 United States
Rhino
DI: 00810060887301
·
Model: Cruiser Hip Abduction Brace Pink - Large
·
MD ORTHOPAEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rhino
- Primary DI
- 00810060887301
- Version / Model
- Cruiser Hip Abduction Brace Pink - Large
- Catalog Number
- 27094
- Company Name
- MD ORTHOPAEDICS, INC.
- Labeler DUNS
- 146220269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-20
- Public Version
- 1
- Public Version Date
- 2023-12-28
- Public Version Status
- New
- Public Device Record Key
- 2d8f5cd8-5431-4f62-b9ab-a66dfa695dee
Device Description
Cruiser Hip Abduction Brace Pink - Large
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ITS | Joint, Hip, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65483 | Infant hip harness | A prefabricated (non-customized) soft orthopaedic orthosis intended to be worn by an infant to help keep the hips and knees bent and the thighs spread apart, typically to treat developmental dysplasia of the hip (DDH). Also referred to as a Pavlik harness, it is in the form of a vest-like harness with adjustable padded straps whereby the infant’s legs are suspended from the shoulders and chest. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810060887301 | GS1 |