Identity
- Trade Name
- BREG FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Model / Reference
- HEEL CUP SILICONE M FDA UDI
Identifiers
- Catalog Number
- 11093 FDA UDI
- Primary DI / UDI-DI
- 00672736013960 FDA UDI
- FDA Product Code
- KYS FDA UDI
- GMDN Term
- Knee support orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Knee support orthosis
Breg by Breg, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Gripper Hinged Knee — MEDICAL SPECIALTIES INCORPORATED · Class I
- DeRoyal — DEROYAL INDUSTRIES, 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
- Breg, Inc.
Sources (1)
- FDA UDI 64df8d9b-70a0-45f4-87ac-7928301b8291 34 fields · synced Jun 8, 2026