NA

Basic Information

• Brand Name: NA
• Primary DI: 00858965006359
• Version / Model: TCL901
• 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: 2019-02-04
• Public Version: 3
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: 1c3eddc1-4148-4bc8-a0a9-b5abcdb99dd0

Device Description

COMBINED SPINAL EPIDURAL TRAY EpiSpin Lock Tuohy Epidural Needle 17G x 3.5“ with SPROTTE® Spinal Needle 25G and EpiLong Soft Catheter, Closed Tip, 19G 0.75% Bupivacaine HCl with 8.25% Dextrose

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
OFT	Spinal Epidural Anesthesia Kit	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64348	Epidural/intrathecal anaesthesia set, medicated	A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent to the intrathecal space and to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent, and both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe), and may include an epidural catheter for continuous-administration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858965006359	GS1
Package	20858965006353	GS1		10	In Commercial Distribution

Customer Contacts

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