FDA.reportPublic FDA data

EF1

Primary DI
00713864000313
Brand
EF1
Company
Medshape, Inc.
Model
DNE-40-150
Device description
Drill Bit, 4.0 x 195mm
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00713864000313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00713864000313007138640003137138640003130713864000313

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
601306413
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00713864000320EF1DNE-50-1502026-11-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00713864000320EF1Medshape, Inc.HTW2026-11-02
07630894822513APTUSMedartis AGHTW2026-11-02
07630894822520APTUSMedartis AGHTW2026-11-02
07630894822605APTUSMedartis AGHTW2026-11-02
07630894822612APTUSMedartis AGHTW2026-11-02
07630894822667APTUSMedartis AGHTW2026-11-02
07630894822674APTUSMedartis AGHTW2026-11-02
03700569679279Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679286Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679293Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679309Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
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