ebner 502 Handle Straight Head

Primary DI
00860002195032
Brand
ebner 502 Handle Straight Head
Company
MAXILON LABORATORIES INC
Model
10325-01
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
2021-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMIFile, Bone, Surgical
GACRasp, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMIFile, Bone, SurgicalDental1
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002195032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002195032008600021950328600021950320860002195032

GMDN Terms#

Term, Definition table
TermDefinition
Bone collection scraperA 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

Contacts#

Phone, Email table
PhoneEmail
(603)-594-9300maxilon@maxilon.com

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 DIBrandModelCatalogPublished
00860002195049ebner 502 Handle 30 degree Up Head Angle10325-032021-10-29
00860002195056ebner 502 Handle 30 degree Down Head Angle10325-022021-10-29
20860002195005Mx-Grafter113022020-08-03
00860002195001Mx-Grafter113022020-03-02
00860002195025ebner 500 Series Blade10561-052020-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196382989MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
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