FDA UDI
In Commercial Distribution
🇺🇸 United States
Cannulated Compression Screw w/ Hexalobular Drive, 4.0mm x 20mm Long
DI: 00810054092858
·
Model: CH4020
·
AVANTI ORTHOPAEDICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cannulated Compression Screw w/ Hexalobular Drive, 4.0mm x 20mm Long
- Primary DI
- 00810054092858
- Version / Model
- CH4020
- Company Name
- AVANTI ORTHOPAEDICS LLC
- Labeler DUNS
- 043505370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-09
- Public Version
- 1
- Public Version Date
- 2022-12-19
- Public Version Status
- New
- Public Device Record Key
- 8b577373-5dce-4c7f-a7c9-e6eeac5fb472
Device Description
Cannulated Compression Screw w/ Hexalobular Drive, 4.0mm x 20mm Long
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 61868 | Cell culture bioreactor | A mains electricity (AC-powered) laboratory instrument designed to cultivate adherent and/or suspension cells for various applications (e.g., T-cell expansion, mesenchymal stem cell expansion, dendritic cell maturation). It consists of a functionally closed hollow compartment with inputs/outputs for cell feeding, media exchange, waste removal and cell harvesting, and typically permits regulation of environmental factors that affect cell growth [e.g., temperature, pH, gas composition]. The device operates with minimal technician input and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810054092858 | GS1 |
Customer Contacts
- Phone
- 610-316-7345
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222967 | 000 |