Home GUDID 00860011139607 EpiZact
Primary DI 00860011139607
Brand EpiZact
Company GuideStar Medical Devices Inc
Model GMD1-001
Device description EpiZact is a single use medical device used during an epidural procedure.
Published 2023-11-30
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FMF Syringe, Piston
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMF Syringe, Piston General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860011139614 Package GS1 10 In Commercial Distribution 00860011139607 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860011139614 00860011139614 860011139614 0860011139614 00860011139607 00860011139607 860011139607 0860011139607
GMDN Terms# Term, Definition table Term Definition Low-resistance epidural syringe A low-friction glass or plastic barrel (cylinder) with plunger intended to be used with a needle typically to locate the epidural space. The user advances the needle until a loss of resistance (LOR) is sensed in the plunger, indicating entry into the epidural space. The syringe may then be disconnected to allow the introduction of a catheter through the needle for diagnostic or therapeutic intervention. This is a single-use device.
Regulatory Flags# DUNS number 204187405 Device count 1 Lot or batch true Expiration date on label true Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10840330704868 ProCure Twin Med, LLC FMF 2026-05-27 10840330704875 ProCure Twin Med, LLC FMF 2026-05-27 08800052609303 "Sure Fine Insulin Syringe 0.3cc 31G x 1/4""" SHINA MED CORPORATION FMF 2026-03-25 08800052609310 "Sure Fine Insulin Syringe 0.3cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609327 "Sure Fine Insulin Syringe 0.3cc 30g x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609334 "Sure Fine Insulin Syringe 0.3cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609341 "Sure Fine Insulin Syringe 0.5cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609358 "Sure Fine Insulin Syringe 0.5cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609365 "Sure Fine Insulin Syringe 0.5cc 30G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609372 "Sure Fine Insulin Syringe 0.5cc 29G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609389 "Sure Fine Insulin Syringe 1.0cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609396 "Sure Fine Insulin Syringe 1.0cc 30g x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609402 "Sure Fine Insulin Syringe 1.0cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609419 "Sure Fine Insulin Syringe 1.0cc 29G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609426 "Sure Fine Insulin Syringe 0.3cc 31G x 1/4""" SHINA MED CORPORATION FMF 2026-03-25 08800052609433 "Sure Fine Insulin Syringe 0.3cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609440 "Sure Fine Insulin Syringe 0.3cc 30g x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609457 "Sure Fine Insulin Syringe 0.3cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609464 "Sure Fine Insulin Syringe 0.5cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609471 "Sure Fine Insulin Syringe 0.5cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609488 "Sure Fine Insulin Syringe 0.5cc 30G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609495 "Sure Fine Insulin Syringe 0.5cc 29G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609501 "Sure Fine Insulin Syringe 1.0cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609518 "Sure Fine Insulin Syringe 1.0cc 30g x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609525 "Sure Fine Insulin Syringe 1.0cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609532 "Sure Fine Insulin Syringe 1.0cc 29G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08699207302028 Set Inject SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI FMF 2026-03-17 08699207305036 Set Inject SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI FMF 2026-03-17 08699207310030 Set Inject SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI FMF 2026-03-17 08699207311006 Set Inject SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI FMF 2026-03-17
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