Manus Medical, LLC

Basic Information

• Brand Name: Manus Medical, LLC
• Primary DI: 00811870037863
• Version / Model: EMLP-20375-1
• Company Name: Manus Medical, LLC
• Labeler DUNS: 800604196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-20
• Public Version: 1
• Public Version Date: 2023-12-28
• Public Version Status: New
• Public Device Record Key: 36bb45e1-52bf-481d-a37f-e6d591c0f0a7

Device Description

LUMBAR PUNCTURE KIT #2

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OGJ	Nerve Block Tray	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12404	Lumbar puncture kit	A collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20811870037867	GS1		10	In Commercial Distribution
Primary	00811870037863	GS1