Surgical Probe Cover Kit 1946

GUDID 10841912106537

PROTEK MEDICAL PRODUCTS, INC.

Intraoperative ultrasound imaging transducer cover

• Primary Device ID: 10841912106537
• NIH Device Record Key: 290467bc-60fa-433f-a4c6-8b898a630bf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Probe Cover Kit
• Version Model Number: 1946
• Catalog Number: 1946
• 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	00841912106530 [Primary]
GS1	10841912106537 [Package]; Contains: 00841912106530; Package: [24 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: 2
• Public Version Date: 2021-05-18
• Device Publish Date: 2020-06-01

On-Brand Devices [Surgical Probe Cover Kit]

• 10841912104755: 1237
• 10841912104021: 1934
• 10841912100832: 1934
• 10841912100825: 1933
• 10841912100818: 1931
• 10841912100801: 1930
• 10841912100795: 1930
• 10841912100788: 1930
• 10841912100771: 1929
• 10841912106537: 1946