Home GUDID 00810169720097 ELEMENT Vascular Access System
Primary DI 00810169720097
Brand ELEMENT Vascular Access System
Company PENUMBRA, INC.
Model ELMNT17F80-A
Device description Element 17 F Vascular Access System 80cm
Published 2024-12-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DYB Introducer, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810169720097 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 00810169720097 00810169720097 810169720097 0810169720097
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.
Regulatory Flags# DUNS number 191077671 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00884450838211 Prelude Roadster™ Merit Medical Systems, Inc. DYB 2026-08-18 00199874352930 Transseptal Puncture Device PROTARYX MEDICAL INC. DYB 2026-07-15 00198715836998 EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING FREUDENBERG MEDICAL, LLC DYB 2026-01-29 00685447005285 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005292 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005308 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005315 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005322 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005339 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005346 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005353 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005360 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005377 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005384 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005391 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005407 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005414 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005421 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005438 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005445 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005452 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005469 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005476 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 10801902190519 ARROW TELEFLEX INCORPORATED DYB 2021-09-02 00685447005605 SupraCross Steerable Sheath Baylis Médicale Cie Inc DYB 2021-04-19 00685447005612 SupraCross Steerable Sheath Baylis Médicale Cie Inc DYB 2021-04-19 00685447005629 SupraCross Steerable Sheath Baylis Médicale Cie Inc DYB 2021-04-19 00685447005643 SureFlex Steerable Guiding Sheath Baylis Médicale Cie Inc DYB 2021-04-19 00389701012353 R2P Destination Slender TERUMO MEDICAL CORPORATION DYB 2020-04-10 00389701012360 R2P Destination Slender TERUMO MEDICAL CORPORATION DYB 2020-04-10