NA

Basic Information

• Brand Name: NA
• Primary DI: 00858965006533
• Version / Model: TDLS203
• 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: 2020-06-15
• Public Version: 2
• Public Version Date: 2023-05-30
• Public Version Status: Update
• Public Device Record Key: f30a0e31-f9e5-413e-8bce-94eab7bff87c

Device Description

SonoPlex Tray 21G x 4'' (100mm) echogenic needle with facet tip, NanoLine coating, 60cm injection tubing, 60cm stimulation cable and 120cm Safersonic Probe Cover & Gel (CUSTOM SINGLE SHOT NERVE BLOCK TRAY)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• 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
46382	Peripheral anaesthesia single-administration set, non-medicated	A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes 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	20858965006537	GS1	NA	10	In Commercial Distribution
Primary	00858965006533	GS1

Customer Contacts

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