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 |