microTargeting™ Sterile Drape Sleeves FC1004

GUDID 00873263009024

microTargeting Sterile Drape Sleeves 20x, for use with STar and MT Drives with motor or encoder option.

FHC, INC.

Patient surgical drape, single-use

• Primary Device ID: 00873263009024
• NIH Device Record Key: c20c4c39-36fb-4163-b858-eff44b374fe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Sterile Drape Sleeves
• Version Model Number: FC1004-00904
• Catalog Number: FC1004
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263009024 [Unit of Use]
GS1	10873263009021 [Primary]
GS1	10873263009045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011775
• Premarket Notification: K011992

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

[00873263009024]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [microTargeting™ Sterile Drape Sleeves]

• 10873263001414: microTargeting Sterile Drape Sleeves 20x, for use with STar and MT Drives with motor or encoder
• 00873263009024: microTargeting Sterile Drape Sleeves 20x, for use with STar and MT Drives with motor or encoder