Guide Needle

GUDID M936BGNS0

Brachytherapy Guide Needle

ISOAID, L.L.C.

Nonimplantable needle guide, single-use

• Primary Device ID: M936BGNS0
• NIH Device Record Key: c9492d0a-58b2-45ed-add5-a37e295e10eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Needle
• Version Model Number: BGNS
• Company DUNS: 002751241
• Company Name: ISOAID, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M936BGNS0 [Primary]

FDA Product Code

• HXK: Holder, Needle; Orthopedic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-02-04

Devices Manufactured by ISOAID, L.L.C.

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• 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.