7FR COAX HEMOSTATIC PROBE

GUDID 00821925039483

CD-B620LA BICOAG BIPOLAR HEMO PROB 2.3MM

Gyrus Acmi, Inc.

Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use Endoscopic electrosurgical electrode, bipolar, single-use

• Primary Device ID: 00821925039483
• NIH Device Record Key: 6fefad12-9d2e-4582-b40f-85852c67afbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7FR COAX HEMOSTATIC PROBE
• Version Model Number: CD-B620LA
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925039483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123319

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-13

Devices Manufactured by Gyrus Acmi, Inc.

• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
• 00810008180990 - nCare: 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
• 00810008180501 - nCare: 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180952 - nCare: 2023-09-25 nCare, SNGL,DRCT SDI,DICOM
• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)