NA

GUDID 20858965006759

EpiLong Soft Tray 17G x 3.5" (90mm) needle with 1cm graduation, plastic stylet and wings, EpiLong Soft 19G x 35'' (90cm) catheter with closed tip and 6 lateral openings (CONTINUOUS EPIDURAL) [10/box]

PAJUNK MEDICAL SYSTEMS, LP

Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated Epidural anaesthesia set, medicated
Primary Device ID20858965006759
NIH Device Record Key040b3faa-5b8e-4ade-99cc-c3819cd370d7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTAL151
Catalog NumberNA
Company DUNS136718553
Company NamePAJUNK MEDICAL SYSTEMS, LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com
Phone(770) 493-6832
Emailinfo@pajunk-usa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858965006755 [Primary]
GS120858965006759 [Package]
Contains: 00858965006755
Package: NA [10 Units]
In Commercial Distribution

FDA Product Code

OGEEpidural Anesthesia Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-28
Device Publish Date2022-06-20

Devices Manufactured by PAJUNK MEDICAL SYSTEMS, LP

20858965006179 - N/A2024-01-24 SonoLong Sono Tray 18G x 2'' (50mm) echogenic needle with Tuohy tip, 60cm injection tubing, 60cm stimulation cable, SonoLong Son
30858965006800 - NA2023-12-15 Lumbar puncture support tray
50858965006828 - SUPPORT TRAY2023-10-23 Custom Support Tray
50858965006811 - NA2023-09-11 Continuous Nerve Block Support Tray
20858965006780 - NA2023-06-26 Continuous Epidural Tray 18Gx4" (103mm)
20858965006797 - NA2023-06-26 Continuous Epidural Tray 18G x 2" (50mm)
20858965006339 - NA2023-06-05 Sprotte Tray 24G x 4'' (103mm) needle with 40mm introducer without Bupivacaine (SPINAL)
20858965006346 - NA2023-06-05 Sprotte Tray 25G x 4'' (103mm) needle with 40mm introducer without Bupivacaine (SPINAL)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.