Ultraxx UNB-8-15-CS-01

GUDID 00827002576193

Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe

COOK INCORPORATED

Nephrostomy catheter
Primary Device ID00827002576193
NIH Device Record Keyc9a677d5-5c02-4dfc-b2a3-c2214e7e40b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraxx
Version Model NumberG57619
Catalog NumberUNB-8-15-CS-01
Company DUNS042823948
Company NameCOOK INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(812)330-5494
Emailsharedservices@cookmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to Light.

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002576193 [Primary]

FDA Product Code

LJECATHETER, NEPHROSTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-29
Device Publish Date2019-10-21

On-Brand Devices [Ultraxx]

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

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