Home GUDID 00816349011764 ZIPwire™
Primary DI 00816349011764
Brand ZIPwire™
Company Lake Region Medical
Model M0066802060
Catalog number M0066802060
Device description Urological guidewire
Published 2020-06-30
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 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 10816349011761 Package GS1 5 In Commercial Distribution 00816349011764 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 10816349011761 10816349011761 00816349011764 00816349011764 816349011764 0816349011764
GMDN Terms# Term, Definition table Term Definition Gastro-urological guidewire, single-use A 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.
Device Sizes# Type, Value, Unit table Type Value Unit Guidewire Diameter 0.035 Inch Guidewire Length 150 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in cool, dry place.
Regulatory Flags# DUNS number 031108704 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Contains natural rubber latex true 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, LLC 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 00816349011733 ZIPwire™ Lake Region Medical EYA 2020-06-30 00816349011740 ZIPwire™ Lake Region Medical EYA 2020-06-30 00816349011757 ZIPwire™ Lake Region Medical EYA 2020-06-30 00816349011788 ZIPwire™ Lake Region Medical EYA 2020-06-30