Guide Needle

GUDID M936BGNS0

Brachytherapy Guide Needle

ISOAID, L.L.C.

Nonimplantable needle guide, single-use
Primary Device IDM936BGNS0
NIH Device Record Keyc9492d0a-58b2-45ed-add5-a37e295e10eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuide Needle
Version Model NumberBGNS
Company DUNS002751241
Company NameISOAID, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM936BGNS0 [Primary]

FDA Product Code

HXKHolder, Needle; Orthopedic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


[M936BGNS0]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2016-02-04

Devices Manufactured by ISOAID, L.L.C.

M936IBKAL9 - Advantage-Load® with Advantage I-125®2024-05-03 Advantage-Load® with I-125 radioactive seeds.
M936IBKAS9 - Advantage-Strand® with Advantage I-125®2024-05-03 Brachytherapy Kit: Advantage-Strand® with I-125 radioactive seeds.
M936IBKASAL9 - Advantage-Strand® and Advantage-Load® with Advantage I-125® 2024-05-03 Brachytherapy Kit: Advantage-Strand® and Advantage-Load® with Advantage I-125® radioactive seeds.
M936IBKSS9 - Secure Strand® with Advantage I-125®2024-05-03 Secure Strand with I-125 radioactive seeds.
M936IBKSSAL9 - Advantage I-125®2024-05-03 Secure Strand and Advantage Load with I-125 radioactive seeds.
M936PBKAL9 - Advantage-Load® with Advantage Pd-103® 2024-05-03 Advantage-Load® with Advantage Pd-103® radioactive seeds.
M936PBKAS9 - Advantage-Strand® with Advantage Pd-103® 2024-05-03 Advantage-Strand® with Advantage Pd-103® radioactive seeds.
M936PBKASAL9 - Advantage-Strand® and Advantage-Load® and Advantage Pd-103® 2024-05-03 Brachytherapy Kit: Advantage-Strand and Advantage-Load with Pd-103 radioactive seeds.

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