Home GUDID H9803108110 NA
Primary DI H9803108110
Brand NA
Company SYNTHES (U.S.A.) LP
Model 310.811
Catalog number 310811
Device description COUNTERSINK W/CENTERING PINS FOR 2.0MM SCREWS/HEX COUPLING
Published 2016-06-30
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 true
Product Codes# Code, Name table Code Name DZJ DRIVER, WIRE, AND BONE DRILL, MANUAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DZJ Driver, Wire, And Bone Drill, Manual Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07611819808423 Direct Marking GS1 0 10887587035536 Primary GS1 0 H9803108110 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07611819808423 07611819808423 7611819808423 10887587035536 10887587035536
GMDN Terms# Term, Definition table Term Definition Surgical countersink, single-use A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a single-use device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 832637081 Device count 1 DM exempt false Premarket exempt false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613327652772 TPX STRYKER CORPORATION DZJ 2026-04-13 00860015267801 EmbedMed 3D LIFEPRINTS UK LTD DZJ 2026-03-30 00810007633343 AccuPlan System Medcad DZJ 2025-10-31 00810007633350 AccuPlan System Medcad DZJ 2025-10-31 00810007633336 AccuPlan System Medcad DZJ 2025-10-30 00860012759446 TECHFIT Techfit Digital Surgery, Inc. DZJ 2025-03-17 00860012759453 TECHFIT Techfit Digital Surgery, Inc. DZJ 2025-03-17 00860012759460 TECHFIT Techfit Digital Surgery, Inc. DZJ 2025-03-17 05420060380747 TRUMATCH Materialise NV DZJ 2025-02-28 00810007633183 AccuPlan System Medcad DZJ 2024-10-18 00810007633190 AccuPlan System Medcad DZJ 2024-10-18 00810007633213 AccuPlan System Medcad DZJ 2024-10-18 00810007633220 AccuPlan System Medcad DZJ 2024-10-18 00810007633237 AccuPlan System Medcad DZJ 2024-10-18 00860012759408 TECHFIT Techfit Digital Surgery, Inc. DZJ 2024-09-13 00860012759415 TECHFIT Techfit Digital Surgery, Inc. DZJ 2024-09-13 00860012759422 TECHFIT Techfit Digital Surgery, Inc. DZJ 2024-09-13 00860011469285 TECHFIT Techfit Digital Surgery, Inc. DZJ 2024-08-28 00860011469261 TECHFIT Techfit Digital Surgery, Inc. DZJ 2024-02-22 00860011469278 TECHFIT Techfit Digital Surgery, Inc. DZJ 2024-02-22 00860011469216 TECHFIT Techfit Digital Surgery, Inc. DZJ 2024-02-06 00860011469223 TECHFIT Techfit Digital Surgery, Inc. DZJ 2024-02-06 00860011469230 TECHFIT Techfit Digital Surgery, Inc. DZJ 2024-02-06 00810007631547 AccuPlan System Medcad DZJ 2023-11-30 00810007632209 AccuPlan System Medcad DZJ 2023-11-02 00810007632223 AccuPlan System Medcad DZJ 2023-11-02 00810007631202 AccuPlan System Medcad DZJ 2023-11-01 00810007631257 AccuPlan System Medcad DZJ 2023-11-01 00810007631264 AccuPlan System Medcad DZJ 2023-11-01 00810007631561 AccuPlan System Medcad DZJ 2023-11-01