Home GUDID 00821925012233 Gyrus ACMI
Primary DI 00821925012233
Brand Gyrus ACMI
Company Gyrus ACMI, LLC
Model 140857
Device description BLACK OVAL TOP PORP DENSE HYDROXYLAPATITE CAP 6.6 MM LENGTH 1.78 MM DIAMETER SHAFT FLUOROPLASTIC SHAFT
Published 2015-10-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true 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 00821925012233 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00821925012233 00821925012233 821925012233 0821925012233
GMDN Terms# Term, Definition table Term Definition Polyethylene craniofacial tissue reconstructive material A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.
Regulatory Flags# DUNS number 007198742 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# 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
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