FDA.reportPublic FDA data

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
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M936BGNS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA 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 DIBrandModelCatalogPublished
M936IIS4721IsoSphereIIS4722026-05-12
M936PDIS4721IsoSpherePdIS4722026-05-12
M936IRLS15SSS9Advantage I-125RSLN-15SSS2025-03-04
M936IRLS15S9Advantage I-125RSLN-15S2025-03-04
M936IRLS15SS9Advantage I-125RSLN-15SS2025-03-04
M936IBKAL9Advantage-Load® with Advantage I-125®IBKA2016-02-04
M936IBKAS9Advantage-Strand® with Advantage I-125®IBKA2016-02-04
M936IBKASAL9Advantage-Strand® and Advantage-Load® with Advantage I-125® IBKA2016-02-04
M936IBKSS9Secure Strand® with Advantage I-125®IBKS2016-02-04
M936IBKSSAL9Advantage I-125®IBKS2016-02-04
M936PBKAL9Advantage-Load® with Advantage Pd-103® PBKA2016-02-04
M936PBKAS9Advantage-Strand® with Advantage Pd-103® PBKA2016-02-04
M936PBKASAL9Advantage-Strand® and Advantage-Load® and Advantage Pd-103® PBKA2016-02-04
M936PBKSS9Secure Strand® with Advantage Pd-103®PBKS2016-02-04
M936PBKSSAL9Secure Strand® and Advantage-Load® with Advantage Pd-103®PBKS2016-02-04
M936IRLS20S9Advantage I-125®RSLN-202022-02-07
M936IRLS20SS9Advantage I-125®RSLN-20RSLN2022-02-07
M936IRLS20SSS9Advantage I-125®RSLN-20RSLN2022-02-07
M936IRLS20S0Advantage I-125®RSLN-20RSLN2022-02-07
M936IRLS20SS0Advantage I-125®RSLN-20RSLN2022-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435097MillenniumAvalign Technologies, Inc.HXK2026-10-15
04058749027969NAFehling Instruments GmbH & Co. KGHXK2026-10-12
00190776432782MillenniumAvalign Technologies, Inc.HXK2026-09-29
00724995268916Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268923Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268930Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268947Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268954Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268961Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268978Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
04054462904747evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904754evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904761evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904778evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904785evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904792evonosevonos GmbH & Co. KGHXK2026-08-21
00850088713428PRINCETONPrinceton Medical Group, Inc.HXK2026-08-14
00840217910392Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910408Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910415Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910422Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910439Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910446Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910453Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910460Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910477Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910484Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
04058749047196NAFehling Instruments GmbH & Co. KGHXK2026-07-17
04058749117387NAFehling Instruments GmbH & Co. KGHXK2026-07-17
00850083275235Intrace USAPILOTIS TECH LLCHXK2026-07-03