Home GUDID 00850024702035 SkyOPS
Primary DI 00850024702035
Brand SkyOPS
Company Sky Surgical, LLC
Model P0003L
Device description Dorsal Bunion Plate, Left
Published 2024-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name HRS Plate, Fixation, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRS Plate, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850024702035 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 00850024702035 00850024702035 850024702035 0850024702035
GMDN Terms# Term, Definition table Term Definition Orthopaedic fixation plate, non-bioabsorbable A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 945017205 Device count 1 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 00190446944331 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446944348 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952213 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952220 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952237 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952244 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952251 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952268 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952275 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952282 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952299 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952305 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952312 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446952329 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-25 00190446950110 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446950172 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446950189 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446950196 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446950202 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446950219 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446951964 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446951971 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446951988 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446951995 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446952015 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446952022 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446952039 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446952046 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446952060 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24 00190446952336 Arsenal Foot Trilliant Surgical, LLC HRS 2026-06-24