FDA.reportPublic FDA data

Renovo Life, LLC

Primary DI
M734RNLA200130
Brand
Renovo Life, LLC
Company
RENOVO LIFE LLC
Model
RNL-A20013
Catalog number
RNL-A20013
Device description
3.8mm Pelvic Drill Guide
Published
2018-01-09
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M734RNLA200130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable 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
M734RNL3101900Renovo Life, LLCRNL-310-190RNL-310-1902017-11-14
M734RNL310190C0Renovo Life, LLCRNL-310-190-CRNL-310-190-C2017-11-14
M734RNL3102150Renovo Life, LLCRNL-310-215RNL-310-2152017-11-14

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Primary DI, Brand, Company table
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