n/a 0894-001-015

GUDID 00859506006005

ACAIA PEARL SCALE 2.0

GAUSS SURGICAL, INC

Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale Blood weighing scale

• Primary Device ID: 00859506006005
• NIH Device Record Key: eda6179d-ed81-4f6d-ab5e-a4bcdb69bbc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: n/a
• Version Model Number: 0894-001-015
• Catalog Number: 0894-001-015
• Company DUNS: 968757448
• Company Name: GAUSS SURGICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00859506006005 [Primary]

FDA Product Code

• MRL: Scale, Sponge, Surgical, Electrically-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-10
• Device Publish Date: 2023-03-02

Devices Manufactured by GAUSS SURGICAL, INC

• 00859506006258 - TRITON: 2023-03-27 TRITON 3L CANISTER INSERT KIT
• 00859506006005 - n/a: 2023-03-10ACAIA PEARL SCALE 2.0
• 00859506006005 - n/a: 2023-03-10 ACAIA PEARL SCALE 2.0
• 00859506006128 - Triton Canister System: 2018-07-26 MediVac Guardian 2L Scanning Label and Insert (PN 11032 and PN 11025)
• 00859506006135 - Triton Canister System: 2018-07-26 MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012)
• 00859506006067 - Triton Sponge System: 2018-07-06
• 00859506006081 - Triton Sponge System-Calibration Card: 2018-07-06
• 00859506006098 - Triton Sponge System- NUI Sensor Bracket: 2018-07-06 NUI Sensor Bracket for Tryten Cart
• 00859506006050 - Triton System (Sponge): 2018-05-15