Sterile Protective Barrier Kit 1648

GUDID 10841912106513

PROTEK MEDICAL PRODUCTS, INC.

Medical equipment drape, single-use

• Primary Device ID: 10841912106513
• NIH Device Record Key: 86940ae9-1264-418a-80bd-b1b520db3346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Protective Barrier Kit
• Version Model Number: 1648
• Catalog Number: 1648
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912106516 [Primary]
GS1	10841912106513 [Package]; Contains: 00841912106516; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970885

FDA Product Code

• MMP: Cover, Barrier, Protective

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-25
• Device Publish Date: 2020-06-01

On-Brand Devices [Sterile Protective Barrier Kit]

• 10841912106520: 1696
• 10841912106513: 1648
• 10841912106506: 1628
• 10841912106490: 1624