Home GUDID G586E97448210 Novo Surgical
Primary DI G586E97448210
Brand Novo Surgical
Company NOVO SURGICAL, INC.
Model E97448-21
Catalog number E97448-21
Device description "zenith cinelli osteotome, double-guarded, 6-1/2"" (16.5 cm), straight, 10.0 mm wide"
Published 2023-12-18
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 G586E97448210 Primary HIBCC 0
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 033029433 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 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 10603295083191 SIGMA DEPUY (IRELAND) HWM 2018-09-24 10603295090403 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090410 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090427 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090434 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090441 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090458 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295122739 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122746 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122753 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122760 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122777 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122784 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122791 NA DEPUY (IRELAND) HWM 2018-09-24 10603295123071 MORELAND DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295123088 MORELAND DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295123095 MORELAND DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295123101 MORELAND DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24
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