n/a 0894-001-015

GUDID 00859506006005

ACAIA PEARL SCALE 2.0

GAUSS SURGICAL, INC

Blood weighing scale
Primary Device ID00859506006005
NIH Device Record Keyeda6179d-ed81-4f6d-ab5e-a4bcdb69bbc5
Commercial Distribution StatusIn Commercial Distribution
Brand Namen/a
Version Model Number0894-001-015
Catalog Number0894-001-015
Company DUNS968757448
Company NameGAUSS SURGICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859506006005 [Primary]

FDA Product Code

MRLScale, Sponge, Surgical, Electrically-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-10
Device Publish Date2023-03-02

Devices Manufactured by GAUSS SURGICAL, INC

00859506006258 - TRITON2023-03-27 TRITON 3L CANISTER INSERT KIT
00859506006005 - n/a2023-03-10ACAIA PEARL SCALE 2.0
00859506006005 - n/a2023-03-10 ACAIA PEARL SCALE 2.0
00859506006128 - Triton Canister System2018-07-26 MediVac Guardian 2L Scanning Label and Insert (PN 11032 and PN 11025)
00859506006135 - Triton Canister System2018-07-26 MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012)
00859506006067 - Triton Sponge System2018-07-06
00859506006081 - Triton Sponge System-Calibration Card2018-07-06
00859506006098 - Triton Sponge System- NUI Sensor Bracket2018-07-06 NUI Sensor Bracket for Tryten Cart
00859506006050 - Triton System (Sponge)2018-05-15

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