Home GUDID 08714729802488 ZIPwire™
Primary DI 08714729802488
Brand ZIPwire™
Company Lake Region Medical
Model M006630221B0
Catalog number M006630221B0
Published 2016-10-31
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 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 08714729802488 Package GS1 5 In Commercial Distribution 08714729875512 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08714729802488 08714729802488 8714729802488 08714729875512 08714729875512 8714729875512
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.
Device Sizes# Type, Value, Unit table Type Value Unit Length 150 Centimeter Outer Diameter 0.035 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool, dry place.
Regulatory Flags# DUNS number 031108704 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 true 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, 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 00816349011764 ZIPwire™ Lake Region Medical EYA 2020-06-30