CEROS

GUDID 00858604006719

A modular computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality.

HAMILTON THORNE, INC.

Spermatozoa/semen analyser IVD, automated Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD Spermatozoa/semen analyser IVD

• Primary Device ID: 00858604006719
• NIH Device Record Key: dc814726-ec94-4d0e-8ac3-ee5e75138971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEROS
• Version Model Number: CEROS
• Company DUNS: 152161337
• Company Name: HAMILTON THORNE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858604006719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920719

FDA Product Code

• GKL: Counter, Cell, Automated (Particle Counter)

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: 2019-12-09
• Device Publish Date: 2019-11-30

Devices Manufactured by HAMILTON THORNE, INC.

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• 00858604006016 - accu-beads®: 2022-04-07 accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and
• 00858604006146 - GM501 Gradient 45%: 2021-05-10 GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006177 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006184 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006191 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006207 - GM501 Gradient 90%: 2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
• 00858604006214 - GM501 Gradient 100%: 2021-05-10 GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with