FDA.reportPublic FDA data

Renovo Life

Primary DI
M734RNLA200150
Brand
Renovo Life
Company
RENOVO LIFE LLC
Model
RNLA20015
Catalog number
RNL-A20015
Device description
T-Wrench
Published
2019-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M734RNLA200150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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
M734RNL3102150Renovo Life, LLCRNL-310-215RNL-310-2152017-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150083466Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150076468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00199150076475Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00840606191616Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191623Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191746Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191753Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191784Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191944Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
03701089541022AMPLITUDEAMPLITUDE SASHXX2026-07-29
03700569670269Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569674649Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569679859Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680282Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680299Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
00824846003205Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
10887587078557NASynthes GmbHHXX2026-07-24
10887587078564NASynthes GmbHHXX2026-07-24
00888118154644LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154651LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154668LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154675LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154682LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154699LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154705LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21