ProV-Access Vascular Access Needle Guide Probe Cover Kit 5416

GUDID 10841912101419

PROTEK MEDICAL PRODUCTS, INC.

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• Primary Device ID: 10841912101419
• NIH Device Record Key: ae5587e2-f021-4378-91f8-8c1018f352ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProV-Access Vascular Access Needle Guide Probe Cover Kit
• Version Model Number: 5416
• Catalog Number: 5416
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912101412 [Primary]
GS1	10841912101419 [Package]; Contains: 00841912101412; Package: [10 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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-16

On-Brand Devices [ProV-Access Vascular Access Needle Guide Probe Cover Kit]

• 10841912101426: 5417
• 10841912101419: 5416
• 10841912101402: 5414
• 10841912101396: 5410