General Purpose Probe Cover Kit 934407

GUDID 00841912100064

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00841912100064
• NIH Device Record Key: abf9f75c-f741-4db8-bf67-02041358cebb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General Purpose Probe Cover Kit
• Version Model Number: 0134
• Catalog Number: 934407
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912100064 [Primary]
GS1	10841912100061 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970893

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [General Purpose Probe Cover Kit]

• 10841912104045: 1020
• 00841912100071: 0135
• 00841912100064: 0134
• 00841912100057: 0133
• 00841912100040: 0131
• 00841912100033: 0129
• 10841912100023: 0128