Custom Healthcare Systems of VA, LLC

GUDID 20811870034941

Manus Medical, LLC

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 20811870034941
• NIH Device Record Key: a27be474-32f0-47f0-acd6-abbbcf07e5b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom Healthcare Systems of VA, LLC
• Version Model Number: KM-19796
• Company DUNS: 800604196
• Company Name: Manus Medical, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
GS1	00811870034947 [Primary]
GS1	20811870034941 [Package]; Contains: 00811870034947; Package: NA [4 Units]; In Commercial Distribution

FDA Product Code

• OKE: Port Introducer Kit

Sterilization

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

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

[20811870034941]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-08
• Device Publish Date: 2021-04-20

Devices Manufactured by Manus Medical, LLC

• 20811870037980 - Manus Medical, LLC: 2024-02-15 WIRE CUTTING SCISSORS 4..75"
• 20811870037973 - Manus Medical, LLC: 2024-02-14 LACERATION TRAY (FACIAL)
• 20811870037881 - Manus Medical, LLC: 2024-02-12 TAA EFFICIENCY KIT
• 20811870037904 - Manus Medical, LLC: 2024-02-12 LIPOGEMS EFFICIENCY KIT TAA
• 20811870037911 - Manus Medical, LLC: 2024-02-12 BONE MARROW BIOPSY TRAY
• 20811870037928 - Manus Medical, LLC: 2024-02-12 THE EYE INSTITUTE OF UTAH LASIK PACK
• 00811870037931 - Manus Medical, LLC: 2024-02-12 TAPE, TRACH TUBE 2'S
• 20811870037942 - Manus Medical, LLC: 2024-02-12 TUBING CLAMP 7.5"