RGK Octane Sub4 OCTANE-SUB4

GUDID 00016958059373

The Sub4 is an ultra lightweight and rigid wheelchair that is perfectly designed to fit you and your lifestyle. No corrosion - Titanium will not rust and is very resistant to corrosion and salt water. Perfect for adventures out and about.

SUNRISE MEDICAL (US) LLC

Push-rim manual wheelchair, non-bariatric
Primary Device ID00016958059373
NIH Device Record Key5bd83fd5-55a7-46e9-9496-8b8df61850a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRGK Octane Sub4
Version Model NumberSub 4
Catalog NumberOCTANE-SUB4
Company DUNS962525056
Company NameSUNRISE MEDICAL (US) LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100016958059373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IORWheelchair, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-13
Device Publish Date2023-09-05

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