GUDID 20858965006483

Spinal Tray SPROTTE® Needle 24G x 3.5“ with 0.75% Bupivacaine HCl with 8.25% Dextrose

PAJUNK MEDICAL SYSTEMS, LP

Intrathecal anaesthesia set, non-medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated Intrathecal anaesthesia set, medicated
Primary Device ID20858965006483
NIH Device Record Key493f15ad-c803-466c-94c7-26d0dae10a41
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTBL151
Company DUNS136718553
Company NamePAJUNK MEDICAL SYSTEMS, LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Phone8889725865
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
GS100858965006489 [Primary]
GS120858965006483 [Package]
Contains: 00858965006489
Package: [10 Units]
In Commercial Distribution
GS150858965006484 [Package]
Contains: 00858965006489
Package: NA [25 Units]
In Commercial Distribution

FDA Product Code

OFUSpinal Anesthesia Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-08
Device Publish Date2019-07-31

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)
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