INRO Surgical Nail

Basic Information

• Brand Name: INRO Surgical Nail
• Primary DI: 00861887000213
• Version / Model: 00-4R
• Catalog Number: 4R
• Company Name: Inro Medical Designs Inc
• Labeler DUNS: 623674272
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-17
• Public Version: 1
• Public Version Date: 2023-08-25
• Public Version Status: New
• Public Device Record Key: 641f41c8-2716-415c-b629-5f9ae90109c7

Device Description

Nail splint for the reconstructive surgery of the nail bed.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16210	Hand/finger splint, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10861887000210	GS1	form filled seal	1	In Commercial Distribution	2024-12-31
Primary	00861887000213	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	14	Millimeter