NA

GUDID 20858965006087

COMBINED SPINAL EPIDURAL TRAY EpiSpin Lock Tuohy Epidural Needle 17G x 3.5“ with SPROTTE® Spinal Needle 25G and EpiLong Soft Catheter, Closed Tip, 19G 0.75% Bupivacaine HCl with 8.25% Dextrose

PAJUNK MEDICAL SYSTEMS, LP

Epidural/intrathecal anaesthesia set, non-medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated Epidural/intrathecal anaesthesia set, medicated
Primary Device ID20858965006087
NIH Device Record Keye5bfae70-f2e5-45d9-a2f2-6dc3c4fed7b8
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTCL101
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 Producttrue
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

Phone888-972-5865
Emailxx@xx.xx
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com
Phone770-493-6832
Emailinfo@pajunk-usa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858965006083 [Primary]
GS120858965006087 [Package]
Contains: 00858965006083
Package: [10 Units]
In Commercial Distribution

FDA Product Code

OFTSpinal Epidural Anesthesia Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-11
Device Publish Date2019-11-01

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.