Bone Marrow Biopsy Tray
General, Plastic Surgery · 21 CFR 878.4800
Open FDA's page for this record- Third party flag
- N
- Life sustain support flag
- N
- Gmp exempt flag
- N
- Summary malfunction reporting
- Ineligible
- Product code
- PXO
- Review panel
- SU
- Medical specialty
- SU
- Device name
- Bone Marrow Biopsy Tray
- Medical specialty description
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Implant flag
- N
- Submission type ID
- 7
- Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Harmonized identifiers (openFDA)
- Registration number
- 1223004, 1928237, 3008552585, 9616088, 1643817, 3009888344, 3004111573, 2245270, 3035858921, 1061124, 3006191977, 1423537, 3017036472, 3007329020, 1220477, 3004519921, 1824619
- FEI number
- 1928237, 3008552585, 3002902735, 3005846326, 1643817, 3009888344, 3004111573, 2245270, 1000120555, 3035858921, 1000512168, 3006191977, 3001236905, 3017036472, 3007329020, 1220477, 1824619