NA

GUDID 20858965006094

COMBINED SPINAL EPIDURAL TRAY EpiSpin Tuohy NRFit™ Epidural Needle 17G x 3.5“ with SPROTTE® NRFit 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
Primary Device ID20858965006094
NIH Device Record Key21abed02-5b7e-466f-a1d9-6864292e44e5
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTCN101
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

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
GS100858965006090 [Primary]
GS120858965006094 [Package]
Contains: 00858965006090
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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-22
Device Publish Date2019-06-12

Devices Manufactured by PAJUNK MEDICAL SYSTEMS, LP

20858965006872 - N/A2024-10-16 Quincke 22Gx90mm Lumbar Puncture Tray
20858965006889 - N/A2024-10-16 Sprotte 22Gx90mm Lumbar Puncture Tray
50858965006866 - N/A2024-07-23 Nerve Block Support Tray
50858965006859 - N/A2024-07-16 Continuous Nerve Block Support Tray
50858965006842 - N/A2024-06-28 Custom Spinal Tray
20858965006834 - N/A2024-05-27 Custom Nerve Block Tray
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

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