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.
| Device Type ID | 2774 |
| Device Name | Lumbar Puncture Tray (adult & Pediatric) |
| Physical State | 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. |
| Technical Method | 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. |
| Target Area | 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. |
| Regulation Description | Hypodermic Single Lumen Needle. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 880.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PWY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2774 |
| Device | Lumbar Puncture Tray (adult & Pediatric) |
| Product Code | PWY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hypodermic Single Lumen Needle. |
| CFR Regulation Number | 880.5570 [🔎] |
| Device Problems | |
|---|---|
Incomplete Or Missing Packaging | 1 |
Needle | 1 |
Kit | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables | II | Feb-07-2018 |