Identity
- Trade Name
- Modular Retractor System FDA UDI
- Generic Name
- Orthopaedic instrument extractor FDA UDI
- Device Name
- The Intech Modular Retractor System was developed in close cooperation with leading Medical Device companies and surgeons to serve a variety of approaches to the spine. This versatile kit allows for a variety of configurations (1, 2, or 4 blades) to allow the surgeon safe and efficient access to the spine for implant placement. 1 kit with infinite possibilities (i.e.. Midline, pedicle-based and 3 to 4 blades retractor configurations...) FDA UDI
- Model / Reference
- MRS-100 FDA UDI
- Description
- The Intech Modular Retractor System was developed in close cooperation with leading Medical Device companies and surgeons to serve a variety of approaches to the spine. This versatile kit allows for a variety of configurations (1, 2, or 4 blades) to allow the surgeon safe and efficient access to the spine for implant placement. 1 kit with infinite possibilities (i.e.. Midline, pedicle-based and 3 to 4 blades retractor configurations...) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810019932502 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic instrument extractor 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
Yes
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 instrument extractor
Modular Retractor System 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 1c81c52c-1c47-45a6-9ea6-e62574c41203 33 fields · synced May 31, 2026