FDA UDI
In Commercial Distribution
🇺🇸 United States
DRIVER, 3.5mm HEX
DI: 00810019931987
·
Model: MRS-118
·
Bradshaw Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DRIVER, 3.5mm HEX
- Primary DI
- 00810019931987
- Version / Model
- MRS-118
- 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
- 52b331ec-fe0c-4b8d-bd78-5f63ea7c55ed
Device Description
A driver, 3.5mm hex is a specialized, hand-held surgical instrument used in orthopedic and spinal procedures. Its specific function is to apply torque to a screw, which in this case is used to fix a threaded shim into a vertebra.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| 36248 | Protective barrier strike-through detector | A device designed to provide a visual and/or auditory signal (an alarm) when it detects penetration (strike-through) of a potential contaminant (e.g., body fluids, microorganisms) through an aseptic barrier such as protective attire. It may detect penetration in several ways; 1) it may be based on the simultaneous use of two gloves on each hand with a layer of gel in the middle that changes colour with fluid contact, detecting the outer glove failure; or 2) it may operate using a flow of very low electrical current and when a closed-circuit is established due to fluid contact between the patient and the healthcare professional (e.g., a surgeon), it gives an alarm. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810019931987 | GS1 |