OnPoint Surgical Cart NK0210301

GUDID 00850051682386

OnPoint Surgical Cart (with pre-installed software) - 3 headsets

OnPoint Surgical, Inc.

Orthopaedic stereotactic surgery system
Primary Device ID00850051682386
NIH Device Record Keydd079158-2894-43f9-9faf-41f42a98175e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnPoint Surgical Cart
Version Model Number1
Catalog NumberNK0210301
Company DUNS080659059
Company NameOnPoint Surgical, Inc.
Device Count1
DM Exempttrue
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850051682386 [Primary]

FDA Product Code

SBFOrthopedic Augmented Reality

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-14
Device Publish Date2024-10-04

On-Brand Devices [OnPoint Surgical Cart]

00850051682485OnPoint Surgical Cart (with pre-installed software) - 2 headsets
00850051682386OnPoint Surgical Cart (with pre-installed software) - 3 headsets
00850051682010OnPoint Surgical Cart (with pre-installed software) - 1 headset

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