NA

Basic Information

• Brand Name: NA
• Primary DI: 00858965006410
• Version / Model: TBL133
• 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: 2019-05-03
• Public Version: 3
• Public Version Date: 2023-05-29
• Public Version Status: Update
• Public Device Record Key: 157e5412-e370-4b81-8ae4-a6b019e014f7

Device Description

Sprotte Tray 22G x 4'' (103mm) needle with 40mm introducer (SPINAL)

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
OFU	Spinal Anesthesia Kit	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34845	Intrathecal anaesthesia set, non-medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes a spinal needle and a syringe, with additional devices utilized for the procedure (e.g., dressings). It is not intended for epidural anaesthesia. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20858965006414	GS1	NA	10	In Commercial Distribution
Primary	00858965006410	GS1

Customer Contacts

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