Identity
- Trade Name
- THREADED SHIM FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- A threaded shim is a component of a modular retractor system, specifically designed for orthopedic and spinal surgery. Its primary function is to securely anchor the retractor blades to the vertebrae. This prevents the blades from shifting or moving during the surgical procedure, which is critical for maintaining a stable surgical corridor and protecting surrounding nerves and soft tissues. FDA UDI
- Model / Reference
- MRS-111 FDA UDI
- Description
- A threaded shim is a component of a modular retractor system, specifically designed for orthopedic and spinal surgery. Its primary function is to securely anchor the retractor blades to the vertebrae. This prevents the blades from shifting or moving during the surgical procedure, which is critical for maintaining a stable surgical corridor and protecting surrounding nerves and soft tissues. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810019931857 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Threaded Shim by Bradshaw Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bradshaw Medical Inc.
Sources (1)
- FDA UDI bd18fa00-12d9-433d-8871-0bdd172267cb 33 fields · synced Jun 8, 2026