Bipolar forceps

GUDID 04059082014791

SOPRO-COMEG GmbH

Laparoscopic grasping forceps, reusable

• Primary Device ID: 04059082014791
• NIH Device Record Key: c2ad7270-6825-48e7-921e-805f5aa619eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar forceps
• Version Model Number: 392 993 117
• 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	04059082014791 [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

[04059082014791]

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 [Bipolar forceps]

• 04059082014852: 392 993 124
• 04059082014821: 392 993 121
• 04059082014814: 392 993 119
• 04059082014807: 392 993 118
• 04059082014791: 392 993 117
• 04059082014753: 392 993 024
• 04059082014722: 392 993 021
• 04059082014715: 392 993 019
• 04059082014708: 392 993 018
• 04059082014692: 392 993 017
• 04059082014579: 392 993 003
• 04059082014562: 392 993 002
• 04059082014555: 392 993 001