Reality 92327

GUDID 10019283923279

Latex Condom 3-ct

MAYER LABORATORIES, INC.

Basic male condom, Hevea-latex

• Primary Device ID: 10019283923279
• NIH Device Record Key: 4e40445d-74bd-4a9a-8be7-47346de925f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reality
• Version Model Number: Ultra Thin
• Catalog Number: 92327
• Company DUNS: 175425982
• Company Name: MAYER LABORATORIES, INC.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00719283923271 [Primary]
GS1	10019283923279 [Package]; Contains: 20019283923276; Package: MASTER CARTON [8 Units]; In Commercial Distribution
GS1	20019283923276 [Package]; Contains: 00719283923271; Package: FOLDED CARTON [12 Units]; In Commercial Distribution
GS1	30019283923273 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K897129

FDA Product Code

• HIS: CONDOM

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Reality]

• 10019283927581: Latex Condom 36-ct
• 10019283923323: Latex Condom 3-ct
• 10019283923279: Latex Condom 3-ct