FDA.reportPublic FDA data

NA

Primary DI
00858965006359
Brand
NA
Company
PAJUNK MEDICAL SYSTEMS, LP
Model
TCL901
Catalog number
NA
Device description
COMBINED SPINAL EPIDURAL TRAYEpiSpin Lock Tuohy Epidural Needle 17G x 3.5“ withSPROTTE® Spinal Needle 25G and EpiLong Soft Catheter, Closed Tip, 19G0.75% Bupivacaine HCl with 8.25% Dextrose
Published
2019-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFTSpinal Epidural Anesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20858965006353PackageGS110In Commercial Distribution
00858965006359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085896500635320858965006353
00858965006359008589650063598589650063590858965006359

GMDN Terms#

Term, Definition table
TermDefinition
Epidural/intrathecal anaesthesia set, non-medicatedA dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe) and may include an epidural catheter for continuous-administration. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-972-5865xx@xx.xx
770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
136718553
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858965006939NATDLS250NA2025-08-28
50858965006934NATDLS250NA2025-08-28
00858965006922NATDLS217NA2025-07-07
50858965006927NATDLS217NA2025-07-07
00858965006892N/ATBL403N/A2025-03-07
00858965006908N/ATBL404N/A2025-03-07
20858965006896N/ATBL403N/A2025-03-07
20858965006902N/ATBL404N/A2025-03-07
00858965006809NATBLU119NA2023-07-13
00858965006878N/ATBL401N/A2024-10-08
00858965006885N/ATBL402N/A2024-10-08
20858965006872N/ATBL401N/A2024-10-08
20858965006889N/ATBL402N/A2024-10-08
00858965006915N/ATDLC211N/A2024-10-07
20858965006919N/ATDLC211N/A2024-10-07
00858965006748NATDLU213NA2023-05-26
00858965006861N/ATDLU205N/A2024-07-15
50858965006866N/ATDLU205N/A2024-07-15
00858965006854N/ATDLU232N/A2024-07-08
50858965006859N/ATDLU232N/A2024-07-08

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Primary DI, Brand, Company table
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