NA

Basic Information

• Brand Name: NA
• Primary DI: 00858965006922
• Version / Model: TDLS217
• Catalog Number: NA
• Company Name: PAJUNK MEDICAL SYSTEMS, LP
• Labeler DUNS: 136718553
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-07
• Public Version: 1
• Public Version Date: 2025-07-15
• Public Version Status: New
• Public Device Record Key: 7e1c26df-0cbb-4e2a-a6ef-e4a4be77e671

Device Description

CUSTOM SINGLE SHOT NERVE BLOCK TRAY (SonoPlex II Needle 20Gx100mm with CIVCO Probe Cover & Gel)

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
OGJ	Nerve Block Tray	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64346	Peripheral anaesthesia single-administration set, medicated	A collection of devices intended for the single-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent with an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50858965006927	GS1		25	In Commercial Distribution
Primary	00858965006922	GS1

Customer Contacts

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