Home GUDID 00850024702455 SkyOPS
Primary DI 00850024702455
Brand SkyOPS
Company Sky Surgical, LLC
Model 001-1-08
Device description Broach, Hallux Limitus/Dorsal Bunion
Published 2024-09-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HTQ Broach
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTQ Broach Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850024702455 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 00850024702455 00850024702455 850024702455 0850024702455
GMDN Terms# Term, Definition table Term Definition Orthopaedic broach A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 945017205 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label 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 10603295079965 AML EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080176 EXCEL TRI-LOCK DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080183 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080190 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080206 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080213 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080220 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080237 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080244 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080251 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080268 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080275 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080282 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080299 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080305 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080312 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080329 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080336 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080343 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080350 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080367 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080374 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080381 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295082057 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082064 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082071 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082088 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082095 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082101 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082118 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24