Plastalume

Basic Information

• Brand Name: Plastalume
• Primary DI: 00082161120230
• Version / Model: 12023
• Company Name: BROWNMED, INC.
• Labeler DUNS: 091999771
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-13
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 2f6405f3-2ede-48df-b7d9-697bf27b8e7c

Device Description

Colles Splint

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILH	Splint, Hand, And Components	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42874	Hand/finger splint, reusable	A prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00082161120230	GS1