FDA UDI
In Commercial Distribution
🇺🇸 United States
SCANLAN® Dennis Rib Cutter
DI: 00846159033700
·
Model: 9909-904
·
SCANLAN INTERNATIONAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SCANLAN® Dennis Rib Cutter
- Primary DI
- 00846159033700
- Version / Model
- 9909-904
- Catalog Number
- 9909-904
- Company Name
- SCANLAN INTERNATIONAL INC
- Labeler DUNS
- 023055619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-24
- Public Version
- 2
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- ef4a47e1-a541-4112-8a25-61e58644af49
Device Description
SCANLAN® Dennis Rib Cutter 20mm Cut Height
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 |
|---|---|---|---|---|
| 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 | 00846159033700 | GS1 |
Customer Contacts
- Phone
- 651-298-0997
- [email protected]