HaloShield

Basic Information

• Brand Name: HaloShield
• Primary DI: 00827002462908
• Version / Model: G46290
• Catalog Number: C-SHIELD-2.0
• Company Name: COOK BIOTECH INCORPORATED
• Labeler DUNS: 945385862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-11
• Public Version: 1
• Public Version Date: 2019-03-19
• Public Version Status: New
• Public Device Record Key: 2bdd4b39-0dd1-42a0-8ff8-5e720c15ae64

Device Description

HaloShield Nipple Protector

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
GBX	CATHETER, IRRIGATION	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13570	Wound shield	A mechanical shield that is designed to form a protective structure over a wound. It may be cage-like and will allow exposure to air and permit access to the injured area while protecting against accidental damage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10827002462905	GS1		5	In Commercial Distribution
Primary	00827002462908	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905766	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store in clean, dry location at room temperature