MonoBalloon URO 1284-70-11S

GUDID 04048223057704

MonoBalloon URO URO ring-anchor balloon Ø 11mm, for extraperitoneal surgery

Pajunk GmbH Medizintechnologie

Laparoscopic access cannula anchor, single-use
Primary Device ID04048223057704
NIH Device Record Key8db210e2-df51-4300-bdc0-530e82b55df5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonoBalloon URO
Version Model Number1284-70-11S
Catalog Number1284-70-11S
Company DUNS317654283
Company NamePajunk GmbH Medizintechnologie
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com

Device Dimensions

Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter
Lumen/Inner Diameter11 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104048223057704 [Package]
Contains: 04048223078280
Package: [5 Units]
In Commercial Distribution
GS104048223078280 [Primary]

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

Devices Manufactured by Pajunk GmbH Medizintechnologie

04048223128817 - SPROTTE®2025-09-25 SPROTTE® 25G x 3 1/2" (90mm) with magnification and Introducer, sterile
04048223129111 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 25G x 4 3/4" (120mm) with magnification and IntroDucer NRFit 40mm, sterile
04048223129517 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 25G x 4" (103mm) with magnification and IntroDucer NRFit 40mm, sterile
04048223129647 - SPROTTE®2025-09-25 SPROTTE® 22G x 2" (50mm), sterile
04048223129678 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 22G x 3 1/2" (90mm) with magnification and IntroDucer NRFit 30mm, sterile
04048223129692 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 27G x 4 3/4" (120mm) with magnification and IntroDucer NRFit 40mm, sterile
04048223129838 - SPROTTE® NRFit2025-09-25 SPROTTE® NRFit 25G x 6" (150mm) with magnification and IntroDucer NRFit 40mm, sterile
04048223129999 - Standard Sprotte Needle2025-09-25 Standard Sprotte Needle 25G x 3 1/2" (90mm), sterile with Introducer and wings
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