nCare

GUDID 00810008180990

nCare,D ,2 DRCT SDI, DICOM, RCRDG

Gyrus Acmi, Inc.

Endoscopic video image processing unit

• Primary Device ID: 00810008180990
• NIH Device Record Key: 6e0d298a-0987-4a9b-bb58-24f8adbc4f4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nCare
• Version Model Number: 1007409
• 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	00810008180990 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-02
• Device Publish Date: 2023-09-22

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