FDA.reportPublic FDA data

FIREFLY®

Primary DI
00851662007209
Brand
FIREFLY®
Company
MIGHTY OAK MEDICAL, INC.
Model
FF-205-01
Device description
PATIENT-SPECIFIC MIDLINE GUIDE
Published
2018-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQCPedicle Screw Placement Guide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQCPedicle Screw Placement GuideOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851662007209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851662007209008516620072098516620072090851662007209

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(720) 398-9703mwylie@mightyoakmedical.com

Regulatory Flags#

DUNS number
024112263
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851662007001FIREFLY® FF-101-XX2016-09-23
00851662007018FIREFLY® FF-102-XX2016-09-23
00851662007025FIREFLY® FF-103-XX2016-09-23
00851662007032FIREFLY® FF-104-322016-09-23
00851662007049FIREFLY® FF-105-242016-09-23
00851662007056FIREFLY® FF-105-502016-09-23
00851662007063FIREFLY® FF-106-1002016-09-23
00851662007070FIREFLY® FF-107-012016-09-23
00851662007087FIREFLY® FF-110-012016-09-23
00851662007094FIREFLY® FF-110-022016-09-23
00851662007100FIREFLY® FF-111-012016-09-23
00851662007117FIREFLY® FF-113-012016-09-23
00851662007124FIREFLY® FF-113-022016-09-23
00851662007131FIREFLY® FF-114-012016-09-23
00851662007148FIREFLY® FF-112-012016-09-23
00851662007155FIREFLY® FF-104-202017-10-25
00851662007162FIREFLY® FF-110-032017-10-25
00851662007179FIREFLY® FF-110-042017-10-25
00851662007186FIREFLY®FF-202-XX2018-10-18
00851662007193FIREFLY® FF-205-022018-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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