Kentec ArmBoard

Basic Information

• Brand Name: Kentec ArmBoard
• Primary DI: 10817522010281
• Version / Model: 404AB
• Catalog Number: 404AB
• Company Name: KENTEC MEDICAL, INC.
• Labeler DUNS: 066175613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-16
• Public Version: 1
• Public Version Date: 2021-12-24
• Public Version Status: New
• Public Device Record Key: a269629b-c4b9-496f-b07b-712c226b32fa

Device Description

404 size armboard

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: 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
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12097	Infant limb immobilizer, reusable	A non-rigid device, usually made of a fabric and/or plastic materials, used to temporarily render parts of an infant's body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. It will typically be used to prevent the patient from interrupting an intravenous (IV) infusion, pulling out a catheter, or interfering with wound care. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817522010281	GS1
Package	20817522010288	GS1	box	48	In Commercial Distribution
Package	30817522010285	GS1	case	288	In Commercial Distribution

Customer Contacts

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