Applicator

GUDID 04059082015132

SOPRO-COMEG GmbH

Vaginal applicator, reusable

• Primary Device ID: 04059082015132
• NIH Device Record Key: dde99950-155d-4fed-a383-9d4889072fba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Applicator
• Version Model Number: 392 999 010
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG GmbH
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059082015132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945266

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04059082015132]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

Devices Manufactured by SOPRO-COMEG GmbH

• 04059082003559 - Thoracoscope: 2019-11-08
• 04059082003757 - Hysteroscope: 2019-11-08
• 04059082003764 - Hysteroscope: 2019-11-08
• 04059082003795 - Hysteroscope: 2019-11-08
• 04059082003818 - Hysteroscope: 2019-11-08
• 04059082003856 - Hysteroscope: 2019-11-08
• 04059082003870 - Hysteroscope: 2019-11-08
• 04059082003894 - Hysteroscope: 2019-11-08