Identity
- Trade Name
- ProSplints FDA UDI
- Generic Name
- Elbow immobilizer FDA UDI
- Model / Reference
- 113010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00802357130108 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Elbow immobilizer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Elbow immobilizer
ProSplints by Medical Specialties Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Elbow immobilizer.
- ManaMed — MANAMED LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Elbow Immobilizer Pedo — XEMAX SURGICAL PRODUCTS, INC. · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Elbow Immobilizer — XEMAX SURGICAL PRODUCTS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medical Specialties Incorporated
Sources (1)
- FDA UDI c030363a-77f1-4ccd-b22d-625f219c5269 32 fields · synced May 30, 2026