SPY-PHI System

GUDID 00810007560014

SPY-PHI Articulating Arm, Table Clamp

AXCESS SURGICAL INNOVATIONS, LLC

Medical table clamp
Primary Device ID00810007560014
NIH Device Record Keyc73c8397-bc38-4276-b7db-0f9fff4ba235
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPY-PHI System
Version Model NumberHH1002
Company DUNS968677414
Company NameAXCESS SURGICAL INNOVATIONS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810007560014 [Primary]

FDA Product Code

FWZOperating Room Accessories Table Tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810007560014]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-06
Device Publish Date2019-08-29

On-Brand Devices [SPY-PHI System]

00810007560021SPY-PHI Articulating Arm, Imaging Head Holder
00810007560014SPY-PHI Articulating Arm, Table Clamp
00810007560007SPY-PHI Articulating Arm, Main Arm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.