FDA UDI
In Commercial Distribution
🇺🇸 United States
Modular Retractor System
DI: 00810019932502
·
Model: MRS-100
·
Bradshaw Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Modular Retractor System
- Primary DI
- 00810019932502
- Version / Model
- MRS-100
- Company Name
- Bradshaw Medical, Inc.
- Labeler DUNS
- 621830582
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-07
- Public Version
- 1
- Public Version Date
- 2025-08-15
- Public Version Status
- New
- Public Device Record Key
- 1c81c52c-1c47-45a6-9ea6-e62574c41203
Device 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...)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63105 | Orthopaedic instrument extractor | A hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810019932502 | GS1 |