NA

Basic Information

• Brand Name: NA
• Primary DI: 00858965006472
• Version / Model: TBL152
• Company Name: PAJUNK MEDICAL SYSTEMS, LP
• Labeler DUNS: 136718553
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-31
• Public Version: 2
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: cc262b3a-307d-4e2e-b5a1-7a6a0de04c42

Device Description

Spinal Tray SPROTTE® Needle 25G x 3.5“ with 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
OFU	Spinal Anesthesia Kit	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64349	Intrathecal anaesthesia set, medicated	A collection of devices intended for the single-administration of an analgesic or anaesthetic agent to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes the pharmaceutical anaesthetic agent, 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	20858965006476	GS1		10	In Commercial Distribution
Primary	00858965006472	GS1
Package	50858965006477	GS1	NA	25	In Commercial Distribution

Customer Contacts

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