Identity
- Trade Name
- FIXED CASE FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Fixed Case - MRS EUDAMEDFixed case or Fixed frame is a specialized part of a modular retractor system. Its function is to provide a rigid, stationary base of support for the entire retractor assembly. It is securely attached to the operating room table rail or a similar fixed point. FDA UDI
- Model / Reference
- MRS-104-04 EUDAMEDMRS-104-01 FDA UDI
- Description
- Fixed case or Fixed frame is a specialized part of a modular retractor system. Its function is to provide a rigid, stationary base of support for the entire retractor assembly. It is securely attached to the operating room table rail or a similar fixed point. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810019931482 EUDAMEDFDA UDI
- Basic UDI-DI
- 081001993MRS104019F EUDAMED
- Direct Marketing DI
- 00810019931482 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L1206 LAPAROSCOPIC AND THORACOSCOPIC SURGERY SPREADERS AND RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Fixed Case by Bradshaw Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bradshaw Medical Inc.
Sources (2)
- FDA UDI b5dc390b-958b-428b-9fd6-9ffe1bde6d43 33 fields · synced Jun 18, 2026
- EUDAMED 63a53847-a362-485a-8f85-abb2f62dfe24 61 fields · synced Jun 18, 2026