Home GUDID M936BGNS0 Guide Needle
Primary DI M936BGNS0
Brand Guide Needle
Company ISOAID, L.L.C.
Model BGNS
Device description Brachytherapy Guide Needle
Published 2016-02-04
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 HXK Holder, Needle; Orthopedic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HXK Holder, Needle; Orthopedic Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M936BGNS0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Nonimplantable needle guide, single-use A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 002751241 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M936IIS4721 IsoSphere IIS472 2026-05-12 M936PDIS4721 IsoSphere PdIS472 2026-05-12 M936IRLS15SSS9 Advantage I-125 RSLN-15SSS 2025-03-04 M936IRLS15S9 Advantage I-125 RSLN-15S 2025-03-04 M936IRLS15SS9 Advantage I-125 RSLN-15SS 2025-03-04 M936IBKAL9 Advantage-Load® with Advantage I-125® IBKA 2016-02-04 M936IBKAS9 Advantage-Strand® with Advantage I-125® IBKA 2016-02-04 M936IBKASAL9 Advantage-Strand® and Advantage-Load® with Advantage I-125® IBKA 2016-02-04 M936IBKSS9 Secure Strand® with Advantage I-125® IBKS 2016-02-04 M936IBKSSAL9 Advantage I-125® IBKS 2016-02-04 M936PBKAL9 Advantage-Load® with Advantage Pd-103® PBKA 2016-02-04 M936PBKAS9 Advantage-Strand® with Advantage Pd-103® PBKA 2016-02-04 M936PBKASAL9 Advantage-Strand® and Advantage-Load® and Advantage Pd-103® PBKA 2016-02-04 M936PBKSS9 Secure Strand® with Advantage Pd-103® PBKS 2016-02-04 M936PBKSSAL9 Secure Strand® and Advantage-Load® with Advantage Pd-103® PBKS 2016-02-04 M936IRLS20S9 Advantage I-125® RSLN-20 2022-02-07 M936IRLS20SS9 Advantage I-125® RSLN-20 RSLN 2022-02-07 M936IRLS20SSS9 Advantage I-125® RSLN-20 RSLN 2022-02-07 M936IRLS20S0 Advantage I-125® RSLN-20 RSLN 2022-02-07 M936IRLS20SS0 Advantage I-125® RSLN-20 RSLN 2022-02-07
Other Devices Sharing Product Codes#