FDA UDI
In Commercial Distribution
🇺🇸 United States
Bethune-Coryllos Rib Shears
DI: 00192896116030
·
Model: 430-362
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bethune-Coryllos Rib Shears
- Primary DI
- 00192896116030
- Version / Model
- 430-362
- Catalog Number
- 430-362
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-28
- Public Version
- 1
- Public Version Date
- 2023-12-06
- Public Version Status
- New
- Public Device Record Key
- 36452a70-14db-4cc8-bb62-c70dfc673c7e
Device Description
Bethune-Coryllos Rib Shears Right Blades
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
- Yes
- 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
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFO | RETRACTOR, SELF-RETAINING | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15038 | Rib guillotine | A manually-operated surgical instrument designed to cut transversely (i.e., transect) one or more ribs during a surgical procedure that requires the opening of the thoracic cavity. It typically consists of a robust metal frame through which runs a sliding blade which is moved by the device operator (e.g., through a squeezing action). It is made of high-grade stainless steel and may be available in various shapes and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896116030 | GS1 |
Customer Contacts
- Phone
- +1(800)821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6 Inch Blade Spread | ||
| Length | 14 | Inch |