MPM Medical Supply (Private Label)

Basic Information

• Brand Name: MPM Medical Supply (Private Label)
• Primary DI: 00859013006093
• Version / Model: TNL0815
• Catalog Number: TNL0815
• Company Name: MANAN MEDICAL PRODUCTS, INC.
• Labeler DUNS: 831737957
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-05
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 111a4950-1b6d-4e34-a843-96e5a2eea988

Device Description

8GA X 15 CM (Target Needle-Locking)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46350	Bone marrow biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20859013006097	GS1	Unit Boxes	10	In Commercial Distribution
Package	10859013006090	GS1	Tyvek Pouch	6	In Commercial Distribution
Primary	00859013006093	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K890925	000

Device Sizes

Type	Value	Unit	Text
Length	15	Centimeter