Baby Gorilla/Gorilla Plating System

Basic Information

• Brand Name: Baby Gorilla/Gorilla Plating System
• Primary DI: 00889795049087
• Version / Model: P99-997-0411
• Catalog Number: P99-997-0411
• Company Name: PARAGON 28, INC.
• Labeler DUNS: 042961576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-17
• Public Version: 1
• Public Version Date: 2019-10-25
• Public Version Status: New
• Public Device Record Key: 4e321717-7a74-41f2-929c-09acb3aa8121

Device Description

Bone Marrow Harvest Needle

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAA	NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47612	Bone marrow explant needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously explant bone marrow (explant is the collection and transfer of living bone marrow from its natural site to a new site, or to a culture medium). The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the sternum, hip bone, or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889795049087	GS1