Reducer

GUDID 04059082015040

SOPRO-COMEG GmbH

Endoscope assembly adaptor

• Primary Device ID: 04059082015040
• NIH Device Record Key: 31011e2b-ac8b-4659-94d7-df6484e10e66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reducer
• Version Model Number: 392 998 010
• 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	04059082015040 [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

[04059082015040]

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

On-Brand Devices [Reducer]

• 04059082015125: 392 999 008
• 04059082015118: 392 999 007
• 04059082015101: 392 999 006
• 04059082015095: 392 999 005
• 04059082015088: 392 999 004
• 04059082015071: 392 999 003
• 04059082015064: 392 999 001
• 04059082015057: 392 999 000
• 04059082015040: 392 998 010
• 04059082015033: 392 998 009
• 04059082015026: 392 998 008
• 04059082015019: 392 998 007
• 04059082014999: 392 998 005
• 04059082014982: 392 998 004
• 04059082014975: 392 998 003
• 04059082014968: 392 998 002
• 04059082014951: 392 998 001