Home GUDID 00196449002429 RIPTIDE
Primary DI 00196449002429
Brand RIPTIDE
Company Tyber Medical, LLC
Model 6ZBC00000
Catalog number 6ZBC00000
Device description Cotton Instrument Kit Sterile
Published 2023-11-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LXH Orthopedic manual surgical instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00196449002429 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 00196449002429 00196449002429 196449002429 0196449002429
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant inserter/extractor, single-use A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 010968002 Device count 1 Premarket exempt true Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00196449002511 LEOS Cannulated Screw System 76312008 76312008 2023-12-08 00196449002528 LEOS Cannulated Screw System 76312010 76312010 2023-12-08 00196449002535 LEOS Cannulated Screw System 76312012 76312012 2023-12-08 00196449002542 LEOS Cannulated Screw System 76312014 76312014 2023-12-08 00196449002559 LEOS Cannulated Screw System 76312016 76312016 2023-12-08 00196449002566 LEOS Cannulated Screw System 76312018 76312018 2023-12-08 00196449002573 LEOS Cannulated Screw System 76312020 76312020 2023-12-08 00196449002580 LEOS Cannulated Screw System 76312022 76312022 2023-12-08 00196449002597 LEOS Cannulated Screw System 76312024 76312024 2023-12-08 00196449002603 LEOS Cannulated Screw System 76312026 76312026 2023-12-08 00196449002610 LEOS Cannulated Screw System 76312028 76312028 2023-12-08 00196449002627 LEOS Cannulated Screw System 76312030 76312030 2023-12-08 00196449002634 LEOS Cannulated Screw System 76312508 76312508 2023-12-08 00196449002641 LEOS Cannulated Screw System 76312510 76312510 2023-12-08 00196449002658 LEOS Cannulated Screw System 76312512 76312512 2023-12-08 00196449002665 LEOS Cannulated Screw System 76312514 76312514 2023-12-08 00196449002672 LEOS Cannulated Screw System 76312516 76312516 2023-12-08 00196449002689 LEOS Cannulated Screw System 76312518 76312518 2023-12-08 00196449002696 LEOS Cannulated Screw System 76312520 76312520 2023-12-08 00196449002702 LEOS Cannulated Screw System 76312522 76312522 2023-12-08
Other Devices Sharing Product Codes# 
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