Home GUDID 00850015358746 RIGICON SURGICAL RETRACTOR
Primary DI 00850015358746
Brand RIGICON SURGICAL RETRACTOR
Company Rigicon, Inc.
Model RSRK-1000
Catalog number RSRK-1000
Device description Rigicon® Surgical Retractor
Published 2024-02-02
Public version status New
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 GAD Retractor
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAD Retractor General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850015358746 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 00850015358746 00850015358746 850015358746 0850015358746
GMDN Terms# Term, Definition table Term Definition Surgical retraction system, single-use A sterile, frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a single-use device.
Regulatory Flags# DUNS number 045247683 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850033207811 RIGICON DILATOM™ 11-12 MM RSSC-1112 2024-06-26 00850033207828 RIGICON DILATOM™ 10-12 MM RSSC-1012 2024-06-26 00850033207842 RIGICON DILATOM™ 13-14 MM RSSC-1314 2024-06-26 00850033207873 RIGICON DILATOM™ 07-08 MM RSSC-0708 2024-06-26 00850033207880 RIGICON DILATOM™ 9-10 MM RSSC-0910 2024-06-26 00850015358289 Rigicon Stainless Steel Furlow Insertion Tool RSSF-1000 RSSF-1000 2024-02-02 00850015358296 Rigicon Stainless Steel Dilator 09-10 mm RSSD-0910 RSSD-0910 2024-02-02 00850015358302 Rigicon Stainless Steel Dilator 11-12 mm RSSD-1112 RSSD-1112 2024-02-02 00850015358319 Rigicon Stainless Steel Dilator 13-14 mm RSSD-1314 RSSD-1314 2024-02-02 00850015358326 Rigicon Stainless Steel Dilator 10-12 mm RSSD-1012 RSSD-1012 2024-02-02 00850015358395 Rigicon Furlow Insertion Tool RSUF-1000 RSUF-1000 2024-02-02 00850015358401 Rigicon HL Dilator 09 – 10 mm RSUD-0910 RSUD-0910 2024-02-02 00850015358418 Rigicon HL Dilator 11 – 12 mm RSUD-1112 RSUD-1112 2024-02-02 00850015358425 Rigicon HL Dilator 13 – 14 mm RSUD-1314 RSUD-1314 2024-02-02 00850015358432 Rigicon HL Dilator 15 – 16 mm RSUD-1516 RSUD-1516 2024-02-02 00850015358449 Rigicon HL Dilator 10 – 12 mm RSUD-1012 RSUD-1012 2024-02-02 00850033207453 Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm RSSL-1012 RSSL-1012 2024-02-02 00850033207460 Rigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mm RSSL-1014 RSSL-1014 2024-02-02 00850033207941 Rigicon Stainless Steel Dilator 15-16 mm RSSD-1516 2024-02-02 00850299008009 RIGI10™ RG1009 RG1009 2019-12-12
Other Devices Sharing Product Codes#