Home GUDID 00860002195025
ebner 500 Series Blade
Primary DI 00860002195025
Brand ebner 500 Series Blade
Company MAXILON LABORATORIES INC
Model 10561-05
Device description The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone grafting. The instrument is comprised of a stainless steel handle and blade (blade labeled for single use). The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle's head. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl.Blades are standardized so that ebner 500 BLADEs can be used with any ebner 500 HANDLE (501, 502... 5nn). Before the clinician's first case, he should become familiar with the instrument including the mounting and removal of the blade.
Published 2020-01-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true
Product Codes# Code, Name table Code Name EMI File, Bone, Surgical GAC Rasp, Surgical, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMI File, Bone, Surgical Dental 1 GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860002195025 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 00860002195025 00860002195025 860002195025 0860002195025
GMDN Terms# Term, Definition table Term Definition Bone collection scraper A sterile, surgical device intended for the manual removal, through scraping, and collection of autogenous bone particles from a patient, typically as part of a dental surgical procedure. It consists of a handle with a scraping blade and a collection chamber. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 949461941 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860002195032 ebner 502 Handle Straight Head 10325-01 2021-10-29 00860002195049 ebner 502 Handle 30 degree Up Head Angle 10325-03 2021-10-29 00860002195056 ebner 502 Handle 30 degree Down Head Angle 10325-02 2021-10-29 20860002195005 Mx-Grafter 11302 2020-08-03 00860002195001 Mx-Grafter 11302 2020-03-02
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10888277374324 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-02-14 10888277382992 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-02-14 10080196382989 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10080196384983 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277374515 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277377004 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277377011 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277377509 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277381971 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277382442 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277384286 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277384415 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277385863 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277386938 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10888277388383 MEDLINE MEDLINE INDUSTRIES, INC. GAC 2025-01-29 10840199507518 Rasp KOROS U.S.A., INC. GAC 2024-05-31 B3561116833ST0 American Medicals American Medicals GAC 2023-01-02 07898506812127 Quinelato Schobell Industrial Ltda EMI 2022-12-08 07898506812134 Quinelato Schobell Industrial Ltda EMI 2022-12-08 14026704793942 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704793959 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704793966 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704793973 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704793980 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704793997 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704798374 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704798398 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704798404 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704798688 PILLING TELEFLEX INCORPORATED GAC 2022-12-08 14026704798749 PILLING TELEFLEX INCORPORATED GAC 2022-12-08