nCare

GUDID 00810008180969

nCare, SNGL, ELA, DICOM

Gyrus Acmi, Inc.

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 00810008180969
• NIH Device Record Key: 13ebb9b1-2777-4a85-8a9b-3b481859882d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nCare
• Version Model Number: 1006538
• Company DUNS: 118498779
• Company Name: Gyrus Acmi, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00810008180969 [Primary]

FDA Product Code

• LMB: Device, Digital Image Storage, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-25
• Device Publish Date: 2022-12-19

On-Brand Devices [nCare]

• 00810008180976: nCare, SNGL, ELA, DICOM, RCRDG
• 00810008180969: nCare, SNGL, ELA, DICOM
• 00810008180952: nCare, SNGL,DRCT SDI,DICOM
• 00810008180921: nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180501: nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180990: nCare,D ,2 DRCT SDI, DICOM, RCRDG
• 00810008180983: nCare, D, DRCT SDI, ELA, DICOM, RCRDG