Identity
- Trade Name
- Unite Medical® FDA UDI
- Generic Name
- Orthosis suspension unit FDA UDI
- Device Name
- The Unite Medical® suspension sleeve is worn in conjunction with a knee orthosis to help suspend brace and prevent knee orthosis from migrating. FDA UDI
- Model / Reference
- Suspension Sleeve (Universal) FDA UDI
- Description
- The Unite Medical® suspension sleeve is worn in conjunction with a knee orthosis to help suspend brace and prevent knee orthosis from migrating. FDA UDI
Identifiers
- Catalog Number
- SS2397 FDA UDI
- Primary DI / UDI-DI
- 00850012035329 FDA UDI
- FDA Product Code
- ITQ FDA UDI
- GMDN Term
- Orthosis suspension unit 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
Yes
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: Orthosis suspension unit
Unite Medical® by Unite Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthosis suspension unit.
- KMEDIC — TELEFLEX INCORPORATED · Class I
- KMEDIC — TELEFLEX INCORPORATED · Class I
- KMEDIC — TELEFLEX INCORPORATED · 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
- Unite Medical, Llc
Sources (1)
- FDA UDI 2f983067-49d3-4bed-9cbd-9075c1d99b89 35 fields · synced Jun 1, 2026