Apex® 3000000A1

GUDID 00851508007028

Apex

INCONTROL MEDICAL, LLC

Pelvic floor muscle exerciser

• Primary Device ID: 00851508007028
• NIH Device Record Key: 35c2c5e2-ba9e-4dee-ab79-03eafc193b4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apex®
• Version Model Number: 3000000A1
• Catalog Number: 3000000A1
• Company DUNS: 052247990
• Company Name: INCONTROL MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(262)373-0422
• Email: info@incontrolmedical.com

Device Dimensions

• Length: 12 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851508007028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141158

FDA Product Code

• KPI: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

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: 2019-03-20
• Device Publish Date: 2016-10-03

Devices Manufactured by INCONTROL MEDICAL, LLC

• 00851508007103 - Attain: 2019-03-27 Attain
• 00851508007004 - InTone®: 2019-03-20 InTone
• 00851508007011 - InTone®MV: 2019-03-20 InToneMV
• 00851508007028 - Apex®: 2019-03-20Apex
• 00851508007028 - Apex®: 2019-03-20 Apex
• 00851508007035 - Apex®M: 2019-03-20 ApexM
• 00851508007042 - InTone® NASP: 2019-03-20 InTone NASP
• 00851508007059 - InTone®MV NASP: 2019-03-20 InToneMV-NASP
• 00851508007073 - InTone® by Viveve: 2019-03-20 InTone by Viveve