Nephro-Stent Nephroureteral Stent Catheter NSL2T-0822H

GUDID 10817640020162

HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 cm Pig-to-Pig

URESIL, LLC

Nephrostomy catheter

• Primary Device ID: 10817640020162
• NIH Device Record Key: c8641e48-5749-4099-bb74-96cdcf596336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nephro-Stent Nephroureteral Stent Catheter
• Version Model Number: NSL2T-0822H
• Catalog Number: NSL2T-0822H
• Company DUNS: 192559557
• Company Name: URESIL, 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: 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: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com

Device Dimensions

• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter
• Catheter Gauge: 8 French
• Length: 22 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817640020165 [Primary]
GS1	10817640020162 [Package]; Contains: 00817640020165; Package: Dispenser [5 Units]; In Commercial Distribution
GS1	20817640020169 [Package]; Package: Shipper [4 Units]; In Commercial Distribution
HIBCC	H862NSL2T0822H0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980889

FDA Product Code

• LJE: Catheter, Nephrostomy

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: 2022-05-06
• Device Publish Date: 2022-04-28

On-Brand Devices [Nephro-Stent Nephroureteral Stent Catheter]

• H862NSL21028H2: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 28 cm Pig-to-Pig
• H862NSL21026H2: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 26 cm Pig-to-Pig
• H862NSL21024H2: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 24 cm Pig-to-Pig
• H862NSL21022H2: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 22 cm Pig-to-Pig
• H862NSL20828H2: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 28 cm Pig-to-Pig
• H862NSL20826H2: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 26 cm Pig-to-Pig
• H862NSL20824H2: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 24 cm Pig-to-Pig
• H862NSL20822H2: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 cm Pig-to-Pig
• H862NSL2T1028H1: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 28 cm Pig-to-Pig
• H862NSL2T1026H1: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 26 cm Pig-to-Pig
• H862NSL2T1024H1: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 24 cm Pig-to-Pig
• H862NSL2T1022H1: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 22 cm Pig-to-Pig
• H862NSL2T0828H1: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 28 cm Pig-to-Pig
• H862NSL2T0826H1: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 26 cm Pig-to-Pig
• H862NSL2T0824H1: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 24 cm Pig-to-Pig
• H862NSL2T0822H1: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 cm Pig-to-Pig
• 10817640020544: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 28 cm Pig-to-Pig
• 10817640020537: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 26 cm Pig-to-Pig
• 10817640020520: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 24 cm Pig-to-Pig
• 10817640020513: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 22 cm Pig-to-Pig
• 10817640020193: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 28 cm Pig-to-Pig
• 10817640020186: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 26 cm Pig-to-Pig
• 10817640020179: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 24 cm Pig-to-Pig
• 10817640020162: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 cm Pig-to-Pig
• 10817640020452: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 28 cm Pig-to-Pig
• 10817640020445: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 26 cm Pig-to-Pig
• 10817640020438: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 24 cm Pig-to-Pig
• 10817640020421: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 22 cm Pig-to-Pig
• 10817640020414: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 28 cm Pig-to-Pig
• 10817640020407: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 26 cm Pig-to-Pig
• 10817640020391: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 24 cm Pig-to-Pig
• 10817640020384: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 cm Pig-to-Pig