Home GUDID 00190776047368 Avalign
Primary DI 00190776047368
Brand Avalign
Company Avalign Technologies, Inc.
Model VM104-1217
Device description Rubin Osteotome, wfinger grip,
Published 2023-09-28
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 HWM OSTEOTOME
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWM Osteotome General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776047368 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 00190776047368 00190776047368 190776047368 0190776047368
GMDN Terms# Term, Definition table Term Definition Plastic surgery osteotome A surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 792528510 Device count 1 Premarket exempt true Lot or batch 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 00810143904666 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143904673 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143907261 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143907278 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143907308 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143907315 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930008 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930015 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930022 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930039 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930046 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930053 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930060 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930077 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930084 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930091 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930107 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930114 SURGIPROS Surgipros, LLC HWM 2026-06-01 09348811099624 INKA The Trustee for KAISER FAMILY TRUST HWM 2026-03-18 09348811110442 INKA The Trustee for KAISER FAMILY TRUST HWM 2026-03-18 09348811111289 INKA The Trustee for KAISER FAMILY TRUST HWM 2026-03-18 10381780503316 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503323 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503330 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503347 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503354 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10603295080770 NA DEPUY (IRELAND) HWM 2018-09-24 10603295080787 NA DEPUY (IRELAND) HWM 2018-09-24 10603295080794 NA DEPUY (IRELAND) HWM 2018-09-24 10603295083160 SIGMA DEPUY (IRELAND) HWM 2018-09-24
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