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Sources: EU EUDAMED, US FDA
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Country: Germany
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PAJUNK GmbH Medizintechnologie
Manufacturer
🇩🇪 Germany
PAJUNK GMBH MEDIZINTECHNOLOGIE
FDA registration
PAJUNK GMBH MEDIZINTECHNOLOGIE·34 products·🇩🇪 Germany
SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE¿ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.
FDA Enforcement
Class II
·Ongoing·Pajunk GmbH·November 6, 2019
PAJUNK GmbH Medizintechnologie
Importer
🇩🇪 Germany
PAJUNK Medical Produkte GmbH
Importer
🇩🇪 Germany
PAJUNK GmbH Medizintechnologie
System producer
🇩🇪 Germany