Home GUDID 00840194496933 3P Small-Mini Frag System
Primary DI 00840194496933
Brand 3P Small-Mini Frag System
Company ORTHOPEDIATRICS CORP.
Model 01-3135-8000
Catalog number 01-3135-8000
Device description 3PSM 3.5 Countersink
Published 2026-06-10
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 false Product Codes# Code, Name table Code Name HRS Plate, fixation, bone HWC Screw, fixation, bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRS Plate, Fixation, Bone Orthopedic 2 HWC Screw, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840194496933 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840194496933 00840194496933 840194496933 0840194496933
GMDN Terms# Term, Definition table Term Definition Surgical countersink, reusable 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 reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 796416191 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 00688346003918 Fine TTO Laboratoires Bodycad Inc HWC 2026-08-03 00688346005356 Fine Osteotomy System - Femoral plate Laboratoires Bodycad Inc HWC 2026-08-03 00688346005356 Fine Osteotomy System - Femoral plate Laboratoires Bodycad Inc HRS 2026-08-03 00688346005387 Fine Osteotomy System - Femoral plate Laboratoires Bodycad Inc HRS 2026-08-03 00688346005387 Fine Osteotomy System - Femoral plate Laboratoires Bodycad Inc HWC 2026-08-03 00688346005523 Fine Osteotomy System - Tibial plate Laboratoires Bodycad Inc HRS 2026-08-03 00688346005523 Fine Osteotomy System - Tibial plate Laboratoires Bodycad Inc HWC 2026-08-03 00688346005554 Fine Osteotomy System - Tibial plate Laboratoires Bodycad Inc HWC 2026-08-03 00688346005554 Fine Osteotomy System - Tibial plate Laboratoires Bodycad Inc HRS 2026-08-03 B562PKSMC0635NSLTI0 WishBone Plate & Screw System Wishbone Medical, Inc. HRS 2021-09-07 B562PKSMC0635NSRTI0 WishBone Plate & Screw System Wishbone Medical, Inc. HRS 2021-09-07 B562MPKCSST4036T0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4036TUS0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4038T0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4038TUS0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4040T0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4040TUS0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4042T0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4042TUS0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4044T0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4044TUS0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4050T0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562MPKCSST4050TUS0 Malleolar Procedure Kit Wishbone Medical, Inc. HWC 2021-02-17 B562PKTCX27LG0 WishBone Plate & Screw System Wishbone Medical, Inc. HWC 2020-12-02 B562PKTCX27LGUS0 WishBone Plate & Screw System Wishbone Medical, Inc. HWC 2020-12-02 B562PKTCX27SM0 WishBone Plate & Screw System Wishbone Medical, Inc. HWC 2020-12-02 B562PKTCX27SMUS0 WishBone Plate & Screw System Wishbone Medical, Inc. HWC 2020-12-02 B562PKTCX35LG0 WishBone Plate & Screw System Wishbone Medical, Inc. HWC 2020-12-02 B562PKTCX35LGUS0 WishBone Plate & Screw System Wishbone Medical, Inc. HWC 2020-12-02 B562PKTCX35SM0 WishBone Plate & Screw System Wishbone Medical, Inc. HWC 2020-12-02
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