Home GUDID D849405045 Ultimate Ice
Primary DI D849405045
Brand Ultimate Ice
Company Ultimate Dental
Model 405045
Published 2016-10-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Product Codes# Code, Name table Code Name ETA Replacement, Ossicular Prosthesis, Total
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D849405045 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Ophthalmic cryosurgical system, mechanical An assembly of mechanical devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal during an ophthalmic surgical procedure. The system typically includes a mechanical regulator to control the flow of cryogen contained in an attached cylinder, and dedicated cryogen-cooled hand-held applicators (probes) to apply the cold to the tissue. The device is typically used to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumours.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Fahrenheit 120 Degrees Fahrenheit
Regulatory Flags# DUNS number 073515165 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00844505014663 OFFSET TITANIUM WILDCAT ALTO Grace Medical, Inc. ETA 2025-07-17 00763000913489 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913496 Bojrab MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913502 Causse/Polycel MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913519 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913526 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913533 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913540 Causse/Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913557 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913564 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913571 Causse/Vincent MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913595 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913601 Flex H/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913625 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913632 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913649 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913656 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913663 Silverstein MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913717 Sheehy/Polycel MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913724 Sheehy/Polycel MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913731 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000913762 N/A MEDTRONIC XOMED, INC. ETA 2025-06-23 00763000033385 HA/C Polycel® Brackmann Total MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000034832 Sheehy HA/C Polycel® P.O.P. MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000034849 Sheehy HA/C Polycel® T.O.P. MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036591 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036607 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036614 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036621 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12 00763000036638 Big Easy® Piston MEDTRONIC XOMED, INC. ETA 2024-05-12