Home GUDID 00613994313157 N/A
Primary DI 00613994313157
Brand N/A
Company MEDTRONIC SOFAMOR DANEK, INC.
Model 778000009
Device description INSTRUMENT 778000009 STRT OSTEOTOME 5.5
Published 2021-09-18
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 00613994313157 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 00613994313157 00613994313157 613994313157 0613994313157
GMDN Terms# Term, Definition table Term Definition Bone cutter A strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 830350380 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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