FDA.reportPublic FDA data

Renovo Life, LLC

Primary DI
M734RNL338100C0
Brand
Renovo Life, LLC
Company
RENOVO LIFE LLC
Model
RNL-338-100-C
Catalog number
RNL-338-100-C
Device description
8.0/2.90mm Cannulated Drill Bit, Coated, TFC, 300mm length
Published
2017-11-14
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
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M734RNL338100C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-844-663-3542info@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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