LE-14-005

GUDID 10852073002439

C R I

Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 10852073002439
• NIH Device Record Key: bf475f61-b226-4fd1-b84b-39e0c15b9b99
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Ball Electrode
• Catalog Number: LE-14-005
• Company DUNS: 130814890
• Company Name: C R I
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com
• Phone: (800) 556-0349
• Email: Sales@ThomasMedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0
• Length: 13 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852073002432 [Primary]
GS1	10852073002439 [Package]; Contains: 00852073002432; Package: Box [5 Units]; In Commercial Distribution
GS1	20852073002436 [Package]; Contains: 00852073002432; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022593

FDA Product Code

• HGI: Electrocautery, Gynecologic (And 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-10

Devices Manufactured by C R I

• 10852073002361 - NA: 2020-07-02 Round Loop, Loop Size: 20mm x 13mm
• 10852073002378 - NA: 2020-07-02 Round Loop, Loop Size: 20mm x 15mm
• 10852073002316 - NA: 2020-06-29 Round Loop, Loop Size: 15mm x 15mm
• 10852073002484 - NA: 2020-06-29 Round Loop, Loop Size: 15mm x 10mm
• 00852073002814 - NA: 2020-01-21 Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based con
• 10852073002231 - NA: 2019-05-27 Square Loop, Loop Size: 10mm x 4mm
• 10852073002248 - NA: 2019-05-27 Round Loop, Loop Size: 5mm x 5mm
• 10852073002255 - NA: 2019-05-27 Round Loop, Loop Size: 10mm x 5mm