Latex Endocavity Probe Cover Kit 3230

GUDID 10841912100887

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, sterile

• Primary Device ID: 10841912100887
• NIH Device Record Key: 61feaf40-cc74-49d2-b1e4-9303bc095151
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Latex Endocavity Probe Cover Kit
• Version Model Number: 3230
• Catalog Number: 3230
• 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: 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912100880 [Primary]
GS1	10841912100887 [Package]; Contains: 00841912100880; Package: [40 Units]; In Commercial Distribution
GS1	20841912100884 [Package]; Contains: 00841912100880; Package: [50 Units]; In Commercial Distribution
GS1	30841912100881 [Package]; Contains: 00841912100880; Package: [24 Units]; In Commercial Distribution
GS1	40841912100888 [Package]; Contains: 00841912100880; Package: [20 Units]; In Commercial Distribution
GS1	50841912100885 [Package]; Contains: 00841912100880; Package: [1100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970891

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 [Latex Endocavity Probe Cover Kit]

• 10841912100917: 3233
• 10841912100887: 3230
• 10841912100870: 3210
• 10841912105950: 3249