EPILONG 0321152-51

GUDID 04048223112151

0321152-51

Pajunk GmbH Medizintechnologie

Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated Epidural anaesthesia set, non-medicated
Primary Device ID04048223112151
NIH Device Record Key6952e98a-4f9b-412e-ba32-109216c069fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPILONG
Version Model Number0321152-51
Catalog Number0321152-51
Company DUNS317654283
Company NamePajunk GmbH Medizintechnologie
Device Count10
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 Datefalse
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
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
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104048223053041 [Previous]
GS104048223112151 [Unit of Use]
GS104048223114964 [Primary]

FDA Product Code

CAZAnesthesia conduction kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-15
Device Publish Date2021-07-07

On-Brand Devices [EPILONG]

14048223025366EpiLong Tuohy needle 17G x 80mm (3 1/4"), with plastic s
14048223021856EpiLong Tuohy needle 18G x 80mm (3 1/4"), with plastic s
14048223021467EpiLong Tuohy needle 18G x 80mm with plastic s
14048223021450EpiLong Tuohy needle 16G x 80mm with plastic s
14048223021443EpiLong Tuohy needle 18G x 90mm, with plastic s
14048223020545EpiLong Tuohy needle 18G x 80mm (3 1/4"), with plastic s
14048223018450EpiLong Tuohy needle 16G x 90mm (3 1/2"), with plastic s
14048223018153EpiLong Tuohy needle 18G x 90mm (3 1/2"), with plastic s
14048223017118EpiLong Tuohy needle 18G x 80mm (3 1/4"), with plastic s
14048223013165EpiLong Tuohy needle 18G x 80mm (3 1/4"), with plastic s
14048223013004EpiLong Tuohy needle 17G x 80mm ( 3 1/4"), with plastic s
14048223012984EpiLong Tuohy needle 16G x 90mm (3 1/2"), with plastic s
14048223012977EpiLong Tuohy needle 17G x 90mm ( 3 1/2"), with plastic s
14048223012953EpiLong Tuohy needle 18G x 90mm (3 1/2"), with plastic s
14048223012946EpiLong Tuohy needle 16G x 90mm (3 1/2"), with plastic s
14048223012915EpiLong Tuohy needle 18G x 90mm (3 1/2"), with plastic s
14048223003098EpiLong Tuohy needle with metal stylet 19Gx45mm 23G x 50 cm Ca
04048223084151131166-608
040482230215380631187-51
040482230214460631152-51
040482230210020621187-51
040482230185900621152-51
040482230131750531157-51
040482230131680531153-51
040482230131510531152-51
040482230131440521152-51
040482230207530431187-51
040482230207460431187-48
040482230184600431157-848
040482230131370431157-51
040482230196410431157-49
040482230131200431157-48
040482230131060431156-48
040482230130900431155-51
040482230130830431155-48
040482230130690421157-48
040482230205480331253-51
040482230253690331253-48
040482230181560331252-51
040482230130210331153-51
040482230130070331153-48
040482230129940331152-51
040482230129870331152-49
040482230129700331152-48
040482230129560321152-51
040482230129490321152-49
040482230031070131156-51
040482230030910131153-50
040482231125330631187-51
040482231125260631152-51

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.