Halo

Basic Information

• Brand Name: Halo
• Primary DI: 00850010608129
• Version / Model: 1216-10006
• Catalog Number: 1216-10006
• Company Name: Medical Devices, Inc.
• Labeler DUNS: 101571834
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-02
• Public Version: 2
• Public Version Date: 2023-06-05
• Public Version Status: Update
• Public Device Record Key: 1daa07a9-fbff-4953-aca0-8572a8c1197e

Device Description

Halo Seal Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to cover a wound and to provide a mechanical barrier Each package contains quantity: 1 Halo Seal.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850010608136	GS1		200	In Commercial Distribution
Primary	00850010608129	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -30 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -30 – 140 Degrees Fahrenheit