Non-Sterile Latex Endocavity Probe Cover

GUDID 00841912104321

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, non-sterile

• Primary Device ID: 00841912104321
• NIH Device Record Key: c9447202-5416-4e79-adde-2063c638291c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Sterile Latex Endocavity Probe Cover
• Version Model Number: 5030
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• 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	00841912104321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970891

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

On-Brand Devices [Non-Sterile Latex Endocavity Probe Cover]

• 00841912104321: 5030
• 40841912100925: 3244
• 30841912100928: 3241
• 20841912104073: 3242
• 20841912100921: 3240