Non-Sterile Probe Storage Covers 1160

GUDID 60841912104262

PROTEK MEDICAL PRODUCTS, INC.

Medical equipment drape, single-use, non-sterile

• Primary Device ID: 60841912104262
• NIH Device Record Key: 2a34ac65-51d4-44dd-bd75-a0e30b09df33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Sterile Probe Storage Covers
• Version Model Number: 1160
• Catalog Number: 1160
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Device Count: 100
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912104260 [Unit of Use]
GS1	50841912104265 [Primary]
GS1	60841912104262 [Package]; Contains: 50841912104265; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970889

FDA Product Code

• KKX: Drape, Surgical

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: 2019-06-18
• Device Publish Date: 2019-06-10

On-Brand Devices [Non-Sterile Probe Storage Covers]

• 40841912104268: 1160
• 60841912104262: 1160
• 80841912104266: 1160