Ultraxx UNB-8-15-CS-01

GUDID 00827002576193

Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe

COOK INCORPORATED

Nephrostomy catheter

• Primary Device ID: 00827002576193
• NIH Device Record Key: c9a677d5-5c02-4dfc-b2a3-c2214e7e40b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultraxx
• Version Model Number: G57619
• Catalog Number: UNB-8-15-CS-01
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• 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: true
• 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

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to Light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002576193 [Primary]

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: 2019-10-29
• Device Publish Date: 2019-10-21

On-Brand Devices [Ultraxx]

• 00827002576209: Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe
• 00827002576193: Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe
• 00827002576186: Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe
• 00827002576179: Ultraxx Nephrostomy Balloon with TFE Sheath
• 00827002576162: Ultraxx Nephrostomy Balloon with TFE Sheath
• 00827002576155: Ultraxx Nephrostomy Balloon with TFE Sheath
• 10827002476582: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
• 10827002476490: Ultraxx Nephrostomy Balloon Set
• 10827002476483: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
• 10827002476476: Ultraxx Nephrostomy Balloon Set
• 10827002476469: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
• 10827002476452: Ultraxx Nephrostomy Balloon Set
• 00827002476585: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
• 00827002476493: Ultraxx Nephrostomy Balloon Set
• 00827002476486: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
• 00827002476479: Ultraxx Nephrostomy Balloon Set
• 00827002476462: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
• 00827002476455: Ultraxx Nephrostomy Balloon Set
• 00827002460386: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
• 00827002460379: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
• 00827002460362: Ultraxx Nephrostomy Balloon Set
• 00827002460355: Ultraxx Nephrostomy Balloon Clear Amplatz Sheath With Radiopaque Stripe
• 00827002460348: Ultraxx Nephrostomy Balloon
• 00827002460331: Ultraxx Nephrostomy Balloon
• 00827002460249: Ultraxx Nephrostomy Balloon Set
• 00827002460232: Ultraxx Nephrostomy Balloon Clear Amplatz Sheath With Radiopaque Stripe
• 00827002303652: Ultraxx Nephrostomy Balloon Set
• 00827002303645: Ultraxx Nephrostomy Balloon With TFE Sheath
• 00827002303584: Ultraxx Nephrostomy Balloon Clear Amplatz Sheath With Radiopaque Stripe
• 00827002303577: Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe