FDA.reportPublic FDA data

NA

Primary DI
20858965006094
Brand
NA
Company
PAJUNK MEDICAL SYSTEMS, LP
Model
TCN101
Catalog number
NA
Device description
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
Published
2019-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
20858965006094PackageGS110In Commercial Distribution
00858965006090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085896500609420858965006094
00858965006090008589650060908589650060900858965006090

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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