Stradis Medical, LLC

GUDID M752COTA81365

Implant Kit

STRADIS MEDICAL LLC

General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated General surgical procedure kit, medicated

• Primary Device ID: M752COTA81365
• NIH Device Record Key: 0e758186-5770-460f-aba3-5621dc85f671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stradis Medical, LLC
• Version Model Number: COTA-8136
• Company DUNS: 043537671
• Company Name: STRADIS MEDICAL LLC
• 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: true
• 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: 1-800-424-8520
• Email: cs@stradishealthcare.com
• Phone: 1-800-424-8520
• Email: cs@stradishealthcare.com
• Phone: 1-800-424-8520
• Email: cs@stradishealthcare.com
• Phone: 1-800-424-8520
• Email: cs@stradishealthcare.com
• Phone: 1-800-424-8520
• Email: cs@stradishealthcare.com
• Phone: 1-800-424-8520
• Email: cs@stradishealthcare.com
• Phone: 1-800-424-8520
• Email: cs@stradishealthcare.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M752COTA81361 [Primary]
HIBCC	M752COTA81365 [Package]; Contains: M752COTA81361; Package: outer box [20 Units]; In Commercial Distribution

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-17
• Device Publish Date: 2020-01-09

On-Brand Devices [Stradis Medical, LLC]

• M752MM8515CP25: Central Line Dressing Change Tray
• M752HCT847325: Dressing Change Tray
• M752IM12655: Dressing Change Kit with SorbaView
• M752TM882315: Port Access Tray
• M752SXPOUCH5: Surgery Prep & Recovery Kit
• M752IM12646: Hazardous Drug Spill Kit
• M752TM882316: Port Access Tray
• M752IM22015: IV START KIT W/CHLORAPREP, GEN
• M752COTA81385: Explant Kit
• M752COTA81365: Implant Kit
• M752HCT35485: 12CC SYRINGE KIT
• M752TM9966NGND0: PICC Insertion Tray
• M752TM996620: PICC Insertion Tray
• M752CPD20003: Catheter Securement Device
• M752HCT20500: 50mL EVA Bags, 2 Port
• M752HCT201006: 100mL EVA Bags, 2 Port
• M752HCT105006: 500mL EVA Bags, 2 Port
• M752HCT43320: 60CC SYRINGE KIT
• M752HCT100GD20: CENTRAL LINE KIT 4MM
• M752HCT6186CP15: Prep Kit
• M752HCT541BP2A5: Central Line Kit
• M752TSBRF6645: TROCAR KIT 4.5MM
• M752TSBRF6630: TROCAR KIT 3.5MM
• M752TM9538CS0: PORT PICC ACCESS TRAY
• M7521000415: NIMBUS II START OF CARE KIT
• M752DC5605: Dressing Change Tray
• M752RWM69KCLYS0: Hypodermoclysis Kit
• M752TMFFTK5: FLUID FILTER TRANSFER KIT
• M752HCT6868PA3NG5: Port Access Tray without gloves
• M752TMCLK25: Central Line Kit
• M752DC560A0: Dressing Change Tray
• M752ZZ09585: Surgical Suture Kit
• M752HCT354822: 12CC SYRINGE KIT
• M752RWM69KTA015: DRESSING CHANGE TRAY W/CHLOR ONE-STEP, TEGADERM, STATLOCK AND DRESSING
• M752HCT200GDBP5: DIALYSIS/CORDIS DRESSING CHANGE KIT BIOPATCH
• M752DC8903CP25: Dressing Change Tray
• M752CD22005: Dressing Change Kit