Piccolo Composite Nailing System Femur Handle
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290109339160 | Date18 Sep 2016 | StatusListed |
Recalls
-
- Terminated Z-1991-2016
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Piccolo Composite Nailing System
- Generic Name
- Orthopaedic implant aiming arm
- Model / Ref / Catalog
- Femur Handle, PFT911500
- Primary DI / UDI-DI
- 07290109339160
- FDA Product Code
- HSB
- GMDN Term
- Orthopaedic implant aiming arm
- Device Class
- Class II
- Regulation Number
- 888.3020
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Carbofix Orthopedics Ltd
Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No