FDA.reportPublic FDA data

EF1

Primary DI
00810028397811
Brand
EF1
Company
Medshape, Inc.
Model
DNE-40-150
Device description
Drill Bit, 4.0 x 195mm
Published
2024-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTWBit, Drill
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810028397811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028397811008100283978118100283978110810028397811

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple drill bitA thin shaft of metal with a sharp distal end intended to drill a small diameter hole into a small bone for insertion of an orthopaedic bone staple, typically for fixation following osteotomy. It may include markings to help gauge the size of the staple to be used and is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
601306413
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
00810028396333EF1DNE-9000-250-CF2024-05-31
00810028396357EF1DNE-9000-350-CF2024-05-31
00810028396371EF1DNE-9000-500-CF2024-05-31
00810028397705EF1DNE-9000-TH-AO2024-05-31
00810028396340EF1DNE-9000-300-CF2024-07-09
00810028396364EF1DNE-9000-400-CF2024-05-31
00810028396388EF1DNE-9000-600-CF2024-05-31
00810028396166EF1DNE-6012-021A2024-07-09
00810028396159EF1DNE-6012-020A2024-05-31
00810028396173EF1DNE-6012-022A2024-05-31
00810028396142EF1DNE-6012-019A2024-05-31
M97012000112300DynaNail1200-01-12302026-10-16
00190446960300DYNANAIL HELIX3100-13-00012026-10-09
00190446960317Active Adaptive3100-14-00012026-10-09
00190446960324DYNANAIL HELIX3100-15-00012026-10-09
00190446960331DYNANAIL HELIX3100-16-00012026-10-09
00190446960348DYNANAIL HELIX3100-17-00452026-10-09
00190446960355DYNANAIL HELIX3100-18-00012026-10-09
00190446960362DYNANAIL HELIX3100-19-00012026-10-09
00190446960379DYNANAIL HELIX3100-20-00012026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100363IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078100370IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078100387IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078101773XMCPEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078103197IO FiX 2.0EXTREMITY MEDICAL, LLCHTW2026-10-29
00842078103227IO FiX 2.0EXTREMITY MEDICAL, LLCHTW2026-10-29
00842078109465CarpalFiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078110379AlignXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112304Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112311Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112328Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112335Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112342Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112489Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112496Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112557Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112564Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078114797Omni MTPEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078114803Omni MTPEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078114865Omni MTPEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078117910Axis PlatingEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078117934Axis PlatingEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078117941Axis PlatingEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078118061Axis PlatingEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078123089Omni Stable AFEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078123331Omni Stable AFEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078124024Omni Stable AFEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078124031Omni Stable AFEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078124048Omni Stable AFEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078125717Omni MiniEXTREMITY MEDICAL, LLCHTW2026-10-29