Home GUDID D943N19817 Power Dental USA
Primary DI D943N19817
Brand Power Dental USA
Company Power Dental U.S.A. Inc.
Model N1981-7
Catalog number N1981-7
Device description GBR KIT SCREW DRIVER HANDLE
Published 2022-01-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes Code Name HWD STARTER, BONE SCREW
Product Code Classifications Code Device Specialty Class HWD Starter, Bone Screw Orthopedic 1
Identifiers And Packaging Identifier Type Agency Package quantity Status D943N19817 Primary HIBCC 0
GMDN Terms Term Definition Intraoperative bone pin/screw, sterile A small sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.
Sterilization Methods Method Moist Heat or Steam Sterilization
Regulatory Flags DUNS number 081305064 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false 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 true Sterilization required before use true Other Devices From This Company Other Devices Sharing Product Codes Primary DI Brand Company Product code Published 00841731134752 Hintermann Series VILEX LLC HWD 2025-09-17 00840019968867 Dakota ALIF Plate System PRECISION SPINE, INC. HWD 2025-03-13 00840180529270 General Instruments ALPHATEC SPINE, INC. HWD 2024-08-01 B07315K0140200 NIDO Pedicle Screw System Kalitec Direct LLC HWD 2023-10-06 B07315K0160200 NIDO Pedicle Screw System Kalitec Direct LLC HWD 2023-10-06 00887868570940 Distal Screw Sheath Biomet Orthopedics, LLC HWD 2023-08-15 00887868570049 Distal Screw Biomet Orthopedics, LLC HWD 2023-06-13 00887868570124 Lag Screw Trochar Biomet Orthopedics, LLC HWD 2023-06-13 00887868570148 Affixus® Biomet Orthopedics, LLC HWD 2023-06-13 00887868570155 Anti-Rotation Screw Sheath Biomet Orthopedics, LLC HWD 2023-06-13 00887868570162 Anti-Rotation Screw Trochar Biomet Orthopedics, LLC HWD 2023-06-13 00887868570179 Anti-Rotation Screw Sleeve Biomet Orthopedics, LLC HWD 2023-06-13 00887868570186 Lag Screw Sheath Biomet Orthopedics, LLC HWD 2023-06-13 00887868570193 Lag Screw Sleeve Biomet Orthopedics, LLC HWD 2023-06-13 00887868570230 Lag Screw Tap Biomet Orthopedics, LLC HWD 2023-06-13 00887868570247 Distal Screw Trochar Biomet Orthopedics, LLC HWD 2023-06-13 00844856069756 Arsenal ALPHATEC SPINE, INC. HWD 2023-05-13 00190376477954 AMP-LTX ALPHATEC SPINE, INC. HWD 2023-04-27 00190376477961 AMP-LTX ALPHATEC SPINE, INC. HWD 2023-04-27 00190376477978 AMP-LTX ALPHATEC SPINE, INC. HWD 2023-04-27 00190376477985 AMP-LTX ALPHATEC SPINE, INC. HWD 2023-04-27 00885556864869 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 00885556864876 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 00885556864883 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 00885556864890 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 00885556864906 Universal2 Total Wrist Implant System Smith & Nephew, Inc. HWD 2023-01-19 00816342024310 Parcus Instrumentation PARCUS MEDICAL LLC HWD 2022-12-06 07640181161522 Starter Keri Medical SA HWD 2022-11-22 00840180511473 General Instrument ALPHATEC SPINE, INC. HWD 2022-10-13 03760225710487 IBS™ IN2BONES HWD 2022-05-09
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