Probe Cover Kits

GUDID 10841912106193

PROTEK MEDICAL PRODUCTS, INC.

Intraoperative ultrasound imaging transducer cover

• Primary Device ID: 10841912106193
• NIH Device Record Key: abef36a4-692b-438a-9629-91b8979423e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Probe Cover Kits
• Version Model Number: 1930
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Device Count: 150
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912106196 [Unit of Use]
GS1	10841912106193 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-05-18
• Device Publish Date: 2019-08-16

On-Brand Devices [Probe Cover Kits]

• 10841912100764: 1471
• 00841912106394: 2270
• 00841912106332: 2450
• 00841912106325: 2320
• 10841912106193: 1930