FDA.reportPublic FDA data

RENOVOLIFE LLC

Primary DI
M734RNL2510020
Brand
RENOVOLIFE LLC
Company
RENOVO LIFE LLC
Model
RNL251002
Catalog number
RNL-251-002
Device description
Intramedullary Fixation Rod, 3.5mm
Published
2016-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M734RNL2510020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tibia nail, non-sterileA non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-844-663-3539info@renovolife.com

Regulatory Flags#

DUNS number
059066475
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M734RNLC300280RENOVO LIFE LLCRNLC30028RNL-C300282019-10-28
M734RNLC300290RENOVO LIFE LLCRNLC30029RNL-C300292019-10-28
M734RNLC300300RENOVO LIFE LLCRNLC30030RNL-C300302019-10-28
M734RNLC300310Renovo LifeRNLC30031RNL-C300312019-10-28
M734RNLC300320Renovo LifeRNLC30032RNL-C300322019-10-28
M734RNLC300330Renovo LifeRNLC30033RNL-C300332019-10-28
M734RNLC300340Renovo LifeRNLC30034RNL-C300342019-10-28
M734RNLC300650Renovo LifeRNLC30065RNL-C300652019-10-28
M734RNLA20008200Renovo LifeRNLA2000820RNL-A20008-202019-10-28
M734RNLA20008250Renovo LifeRNLA2000825RNL-A20008-252019-10-28
M734RNLA20008300Renovo LifeRNLA2000830RNL-A20008-302019-10-28
M734RNLA20008350Renovo LifeRNLA2000835RNL-A20008-352019-10-28
M734RNLA20008400Renovo LifeRNLA2000840RNL-A20008-402019-10-28
M734RNLA20008450Renovo LifeRNLA2000845RNL-A20008-452019-10-28
M734RNLA20008500Renovo LifeRNLA2000850RNL-A20008-502019-10-28
M734RNLA200140Renovo LifeRNLA20014RNL-A200142019-10-28
M734RNLA200150Renovo LifeRNLA20015RNL-A200152019-10-28
M734RNLA200130Renovo Life, LLCRNL-A20013RNL-A200132018-01-09
M734RNL3101900Renovo Life, LLCRNL-310-190RNL-310-1902017-11-14
M734RNL310190C0Renovo Life, LLCRNL-310-190-CRNL-310-190-C2017-11-14

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Primary DI, Brand, Company table
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