ClosureFast

GUDID 20884521140353

Micro Introducer Sheath Set

Covidien LP

General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable

• Primary Device ID: 20884521140353
• NIH Device Record Key: 146e391a-96e5-4af4-ad77-0d158a7481a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClosureFast
• Version Model Number: MIS-7F11
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Catheter Gauge: 7 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521140356 [Primary]
GS1	20884521140353 [Package]; Contains: 10884521140356; Package: PACK_OR_INNER_PACK [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780126

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-09-29
• Device Publish Date: 2017-05-25

On-Brand Devices [ClosureFast]

• 10884521181816: Procedure Pack
• 10884521174924: Endovenous Radiofrequency Ablation (RFA) Catheter,3 cm Heating Element,7 Fr/Ch (2.3 mm) x 60 cm
• 10884521058071: Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x 60 cm
• 10884521058057: Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x 100 cm
• 20884521140353: Micro Introducer Sheath Set
• 20884521140308: Introducer Sheath Set
• 20884521173528: Introducer Sheath Set
• 20884521140292: Micro Introducer Sheath Set
• 20884521592626: Guidewire Single Ended, SS, Fixed Core
• 20884521058122: Ultrasound Probe Cover,6"" x 96"" (15.2 cm x 2.4 m)
• 20884521140407: Tumescent Infiltration Kit
• 20884521140384: Micro Puncture Kit
• 20884521140377: Micro Puncture Kit
• 10884521140417: Tumescent Pump Foot Pedal,Gradual Control
• 20884521140223: Guidewire,Single Ended, PTFE, Fixed Core,0.018"" (0.46 mm) x 45 cm
• 10884521140424: Tumescent Pump Foot Pedal,On/Off Control
• 20884521173511: Arterial Needle,Echogenic Tip,21 G (0.813 mm) x 2.75"" (70 mm)
• 20884521140261: Guidewire,Double Ended, PTFE, Fixed Core,0.035"" (0.89 mm) x 45 cm
• 20884521140254: Guidewire,J Tip, PTFE, Fixed Core,0.025"" (0.64 mm) x 260 cm
• 20884521140247: Guidewire,Double Ended, PTFE, Fixed Core,0.025"" (0.64 mm) x 150 cm
• 20884521140193: Arterial Needle,21 G (0.813 mm) x 2.75"" (70 mm)
• 20884521140186: Arterial Needle,Ultra Thin Wall with Echogenic Tip,19 G (1.067 mm) x 2.75"" (70 mm)
• 20884521140179: Arterial Needle,Ultra Thin Wall,19 G (1.067 mm) x 2.75"" (70 mm)
• 20884521140209: Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
• 20884521140216: Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m)