The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing…
The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of MACI – (Container, specimen mailer and storage, temperature controlled, sterile)
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1).
Record
Regulatory record for Cartilage Biopsy Transport Kit | Listed by | Vericel Corporation, United States |
| FDA product code | KDW |
| Device type | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2024-02-26 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Do not freeze Cartilage Biopsy Transport Medium or gel packs; Special storage condition: Keep gel packs and box with remaining contents at room temperature; Special storage condition: Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F); Special storage condition: Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at; Special storage condition: Do no expose Cartilage Biopsy Transport Medium to direct sunlight |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.