Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray - 22 G x 1 1/2 Inch Spinal Needle with Manometer

Safe
Safe-T - 4302CSP

A collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PWY

Device Name: Lumbar Puncture Tray (Adult & Pediatric)

Device Class: 2

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.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.

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.

Submission Type ID: 7

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: 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.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

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.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.

Regulation Number: 880.5570

Third Party Flag: N

Medical Specialty: HO

Device Id: 50885403107786

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403107788

Package Quantity: 10

Package Discontinue Date: 12/23/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 10885403107788

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A