FDA UDI
In Commercial Distribution
🇺🇸 United States
RIGHT ROTATIVE ARM
DI: 00810019931512
·
Model: MRS-106-R
·
Bradshaw Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RIGHT ROTATIVE ARM
- Primary DI
- 00810019931512
- Version / Model
- MRS-106-R
- Company Name
- Bradshaw Medical, Inc.
- Labeler DUNS
- 621830582
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-08
- Public Version
- 1
- Public Version Date
- 2025-08-18
- Public Version Status
- New
- Public Device Record Key
- f8006302-92a0-4866-a50b-3407ed9212d8
Device Description
A right rotative arm is a multi-jointed, mechanical support system used in the operating room. Its primary function is to securely hold and precisely position surgical instruments, cameras, or other devices during a procedure. The term "rotative" emphasizes the ability of the arm to rotate and swivel in multiple directions, offering a high degree of flexibility and a wide range of motion.
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 |
|---|---|---|---|---|
| 35504 | Blood pressure transducer holder | A device used to secure a pressure transducer used for invasive blood pressure measurement at a desired height. The holder can be fastened to (e.g., a bed or an operating table) and can be adjusted so that the transducer is at the same level as the heart of the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810019931512 | GS1 |