Home GUDID M248239012ND1 IPP-ON®
Primary DI M248239012ND1
Brand IPP-ON®
Company NEWDEAL
Model 239012ND
Device description The proximal PIP Fusion hand drill is used to prepare the proximal phalanx and to define the size of the implant. This model is size 1.
Published 2017-05-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HTO REAMER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTO Reamer Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780045014 Primary GS1 0 M248239012ND1 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780045014 10381780045014
GMDN Terms# Term, Definition table Term Definition Manual surgical rotary handpiece, reusable A manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 536935331 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 true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B356JB405140 American Medicals American Medicals HTO 2026-07-06 00889024701502 Identity® Shoulder System Zimmer, Inc. HTO 2026-06-10 00889024701519 Identity® Shoulder System Zimmer, Inc. HTO 2026-06-10 00810094692797 Tibial Reamer, Square Tip, Klassic ONE 25/50mm TOTAL JOINT ORTHOPEDICS, INC. HTO 2026-06-09 00810030810575 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810582 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810599 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810605 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810612 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810629 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810636 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810643 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810650 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810667 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810674 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810681 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810698 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810704 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-06-01 00810030810414 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810421 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810438 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810445 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810452 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810469 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810476 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810483 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810490 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810506 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810513 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31 00810030810520 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTO 2026-05-31
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