FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgical Direct
DI: B382SDI921050
·
Model: SDI92105
·
Surgical Direct, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Surgical Direct
- Primary DI
- B382SDI921050
- Version / Model
- SDI92105
- Catalog Number
- SDI92105
- Company Name
- Surgical Direct, Inc.
- Labeler DUNS
- 124367223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-03
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- 5ecac304-4a9d-48dc-83b9-eb02db4dd5e9
Device Description
8 inch Ferris-Smith Kerrison, 40 Degree Up Cutting, 5mm with Detachable Shaft
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 |
|---|---|---|---|---|
| HTX | RONGEUR | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32853 | Orthopaedic joint/limb rongeur | A hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B382SDI921050 | HIBCC |
Customer Contacts
- Phone
- +1 (800) 519-3293
- [email protected]