FDA UDI
In Commercial Distribution
🇺🇸 United States
Bradshaw Medical
DI: 00810019931529
·
Model: HRC212312
·
Bradshaw Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bradshaw Medical
- Primary DI
- 00810019931529
- Version / Model
- HRC212312
- Catalog Number
- HRC601
- Company Name
- Bradshaw Medical, Inc.
- Labeler DUNS
- 621830582
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-13
- Public Version
- 2
- Public Version Date
- 2023-11-08
- Public Version Status
- Update
- Public Device Record Key
- 2d2458e2-356a-40ff-bef5-558b6b5bb321
Device Description
Handheld Ratcheting Rod Cutter,3.2mm, 3.5mm Silpad Black Sold as OEM
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| HXZ | Cutter, Wire | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44800 | Internal spinal fixation system cable cutter | A scissors-like, heavy-duty, hand-held surgical instrument specifically designed to cut steel cables used as part of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically designed to cut the cable in situ. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810019931529 | GS1 |
Customer Contacts
- Phone
- 12629251374
- [email protected]