Home GUDID 00821925009967 SUREGLIDE Guidewire 0.038" (0.97mm) x 150cm Regular Body, 3cm Straigh
Primary DI 00821925009967
Brand SUREGLIDE Guidewire 0.038" (0.97mm) x 150cm Regular Body, 3cm Straigh
Company Gyrus Acmi, Inc.
Model 38BX
Published 2018-09-11
Public version status New
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 EYA STYLET, URETERAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EYA Stylet, Ureteral Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925009967 Package GS1 5 In Commercial Distribution 00821925006034 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 00821925009967 00821925009967 821925009967 0821925009967 00821925006034 00821925006034 821925006034 0821925006034
GMDN Terms# Term, Definition table Term Definition Gastro-urological guidewire, single-use A sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.
Regulatory Flags# DUNS number 007198742 Device count 1 DM exempt false Premarket exempt true 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 false 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 00821925003446 GYRUS ACMI, INC Gyrus Acmi, Inc. EYA 2024-07-24 G586UR96286210 Novo Surgical NOVO SURGICAL, INC. EYA 2023-12-18 G586UR96286410 Novo Surgical NOVO SURGICAL, INC. EYA 2023-12-18 00842962125588 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-04-03 00842962125595 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-04-03 00842962125601 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-04-03 00842962125618 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-04-03 00842962125625 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125632 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125649 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125656 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125670 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125687 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125694 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125700 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125717 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125724 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125731 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125748 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125755 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125762 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125809 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125816 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842962125823 HNM MEDICAL HNM STAINLESS, LLC. EYA 2023-03-29 00842331134531 Novo Surgical Inc. NOVO SURGICAL, INC. EYA 2022-11-10 00842331135897 Novo Surgical Inc. NOVO SURGICAL, INC. EYA 2022-11-10 00816349011726 ZipWire Lake Region Medical EYA 2020-06-30 10816349011730 ZipWire Lake Region Medical EYA 2020-06-30 10816349011747 ZipWire Lake Region Medical EYA 2020-06-30 10816349011754 ZipWire Lake Region Medical EYA 2020-06-30