Home GUDID 00866614000115 Galea Elevator
Primary DI 00866614000115
Brand Galea Elevator
Company ARKIS BIOSCIENCES INC.
Model 41.312.101
Catalog number 41.312.101
Device description The Galea Elevator is a stainless-steel, reusable, manual surgical instrument designed to retract and elevate scalp tissue.
Published 2019-04-25
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx 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 00866614000115 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 00866614000115 00866614000115 866614000115 0866614000115
GMDN Terms# Term, Definition table Term Definition Hand-held surgical retractor, reusable A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 078846878 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10866614000181 Subcutaneous Guidewire - Medium 41.240.502 41.240.502 2018-12-14 10866614000198 Subcutaneous Guidewire - Large 41.240.503 41.240.503 2018-12-14 10866614000105 CerebroFlo EVD Catheter Set 37.550.501 37.550.501 2019-10-24 00866614000108 CerebroFlo EVD Catheter Set 37.550.101 37.550.101 2017-12-15 00866614000122 Single Pass Tunneling Guidewire - Large 41.157.103 41.157.103 2018-12-14 00866614000139 Single Pass Tunneling Guidewire - Medium 41.157.102 41.157.102 2018-12-14 00866614000146 Single Pass Tunneling Guidewire - Small 41.157.101 41.157.101 2018-12-14 00866614000153 Precision Tunneler - Small 41.020.501 41.020.501 2018-12-13 00866614000160 Precision Tunneler - Medium 41.020.502 41.020.502 2018-12-13 00866614000177 Precision Tunneler - Large 41.020.503 41.020.503 2018-12-13
Other Devices Sharing Product Codes# 
arkisbiosciences.com
integralife.com