HaloShield C-SHIELD-2.0

GUDID 10827002462905

HaloShield Nipple Protector

COOK BIOTECH INCORPORATED

Wound shield

• Primary Device ID: 10827002462905
• NIH Device Record Key: 2bdd4b39-0dd1-42a0-8ff8-5e720c15ae64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HaloShield
• Version Model Number: G46290
• Catalog Number: C-SHIELD-2.0
• Company DUNS: 945385862
• Company Name: COOK BIOTECH INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002462908 [Primary]
GS1	10827002462905 [Package]; Contains: 00827002462908; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905766

FDA Product Code

• GBX: CATHETER, IRRIGATION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-19
• Device Publish Date: 2019-03-11

On-Brand Devices [HaloShield]

• 10827002462905: HaloShield Nipple Protector
• 10827002462899: HaloShield Nipple Protector