FDA.reportPublic FDA data

MAXI-DRIVER

Primary DI
10845854011386
Brand
MAXI-DRIVER
Company
Conmed Corporation
Model
L191
Catalog number
L191
Device description
MAXI-DRIVER Blade, Oscillating, Knee, Coarse Diamond, 1.27x90.0x25.4mm
Published
2021-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845854011386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084585401138610845854011386

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, oscillating, single-useA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800053401531SharkCutTechcord co.,LtdGFA2024-04-16
08800053401548SharkCutTechcord co.,LtdGFA2024-04-16
08800053401586SharkCutTechcord co.,LtdGFA2024-04-16
08800053401593SharkCutTechcord co.,LtdGFA2024-04-16
08800053401616SharkCutTechcord co.,LtdGFA2024-04-16
08800053401623SharkCutTechcord co.,LtdGFA2024-04-16
08800053401647SharkCutTechcord co.,LtdGFA2024-04-16
08800053401654SharkCutTechcord co.,LtdGFA2024-04-16
08800053401678SharkCutTechcord co.,LtdGFA2024-04-16
08800053401692SharkCutTechcord co.,LtdGFA2024-04-16
08800053401142SharkCutTechcord co.,LtdGFA2024-04-15
08800053401159SharkCutTechcord co.,LtdGFA2024-04-15
08800053401166SharkCutTechcord co.,LtdGFA2024-04-15
08800053401173SharkCutTechcord co.,LtdGFA2024-04-15
08800053401180SharkCutTechcord co.,LtdGFA2024-04-15
08800053401197SharkCutTechcord co.,LtdGFA2024-04-15
08800053401203SharkCutTechcord co.,LtdGFA2024-04-15
08800053401210SharkCutTechcord co.,LtdGFA2024-04-15
08800053401227SharkCutTechcord co.,LtdGFA2024-04-15
08800053401234SharkCutTechcord co.,LtdGFA2024-04-15
08800053401241SharkCutTechcord co.,LtdGFA2024-04-15
08800053401258SharkCutTechcord co.,LtdGFA2024-04-15
08800053401289SharkCutTechcord co.,LtdGFA2024-04-15
08800053401296SharkCutTechcord co.,LtdGFA2024-04-15
08800053401302SharkCutTechcord co.,LtdGFA2024-04-15
08800053401319SharkCutTechcord co.,LtdGFA2024-04-15
08800053401326SharkCutTechcord co.,LtdGFA2024-04-15
08800053401333SharkCutTechcord co.,LtdGFA2024-04-15
08800053401340SharkCutTechcord co.,LtdGFA2024-04-15
08800053401357SharkCutTechcord co.,LtdGFA2024-04-15