N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00858965006908
• Version / Model: TBL404
• Catalog Number: N/A
• Company Name: PAJUNK MEDICAL SYSTEMS, LP
• Labeler DUNS: 136718553
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-07
• Public Version: 1
• Public Version Date: 2025-03-17
• Public Version Status: New
• Public Device Record Key: 9eabb559-1978-4c9c-ade3-696da58fe588

Device Description

Sprotte 20Gx90mm Lumbar Puncture Tray

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PWY	Lumbar Puncture Tray (Adult & Pediatric)	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12404	Lumbar puncture kit	A collection of devices intended for transient percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to obtain a sample of cerebrospinal fluid (CSF). Typical components include a spinal needle and collection tubes for the CSF; a drainage catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20858965006902	GS1	N/A	10	In Commercial Distribution
Primary	00858965006908	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]