Key Surgical Indicator Dot Locking Tags

GUDID 00849771001959

Indicator Dot Locking Tag, Steam Sterilization. 100 Tags

KEY SURGICAL, INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 00849771001959
• NIH Device Record Key: 6c6c2f0e-f215-4aec-8b0b-a48ce2d64272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Key Surgical Indicator Dot Locking Tags
• Version Model Number: LS-100
• Company DUNS: 604056226
• Company Name: KEY SURGICAL, INC.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: 8005417995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771001959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890755

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-30
• Device Publish Date: 2019-12-20

On-Brand Devices [Key Surgical Indicator Dot Locking Tags]

• 00849771033042: Indicator Dot Locking Tag, Red, Steam Sterilization. 1000 Tags
• 00849771033035: Indicator Dot Locking Tag, Steam Sterilization. 1000 Tags
• 00849771032830: Indicator Dot Locking Tag, Steam Sterilization. 300 Tags
• 00849771032588: Indicator Dot Locking Tag, Steam Sterilization. 100 Tags
• 00849771031307: Indicator Dot Locking Tag, Steam Sterilization. 100 Tags
• 00849771001966: Indicator Dot Locking Tag, Red, Steam Sterilization. 100 Tags
• 00849771001959: Indicator Dot Locking Tag, Steam Sterilization. 100 Tags