FDA UDI
In Commercial Distribution
🇺🇸 United States
BITE COMPRESSION SCREWS
DI: 18056099647243
·
Model: 1
·
ORTHOFIX SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BITE COMPRESSION SCREWS
- Primary DI
- 18056099647243
- Version / Model
- 1
- Catalog Number
- 001-A-40007
- Company Name
- ORTHOFIX SRL
- Labeler DUNS
- 438793622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-21
- Public Version
- 4
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- 5d677e37-5c37-44c0-acda-08cb5918a9b2
Device Description
JOINT COMPRESSION FORCEPS
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44378 | Bone distraction forceps | A hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18056099647243 | GS1 |
Customer Contacts
- Phone
- +0390456719000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132893 | 000 |