Lantern Surgical Assistant (HSA) 405204

GUDID 00810832031451

Reference Sensor (RS), LSA

ORTHALIGN, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00810832031451
NIH Device Record Key680e395b-0e98-48c4-88a5-04902e727fe2
Commercial Distribution StatusIn Commercial Distribution
Brand NameLantern Surgical Assistant (HSA)
Version Model Number405204
Catalog Number405204
Company DUNS023266163
Company NameORTHALIGN, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-582-0879
EmailcustomerService@Orthalign.com
Phone866-582-0879
EmailcustomerService@Orthalign.com
Phone866-582-0879
EmailcustomerService@Orthalign.com
Phone866-582-0879
EmailcustomerService@Orthalign.com
Phone866-582-0879
EmailcustomerService@Orthalign.com
Phone866-582-0879
EmailcustomerService@Orthalign.com
Phone866-582-0879
EmailcustomerService@Orthalign.com
Phone866-582-0879
EmailcustomerService@Orthalign.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810832031451 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810832031451]

Moist Heat or Steam Sterilization


[00810832031451]

Moist Heat or Steam Sterilization


[00810832031451]

Moist Heat or Steam Sterilization


[00810832031451]

Moist Heat or Steam Sterilization


[00810832031451]

Moist Heat or Steam Sterilization


[00810832031451]

Moist Heat or Steam Sterilization


[00810832031451]

Moist Heat or Steam Sterilization


[00810832031451]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-08
Device Publish Date2022-06-30

On-Brand Devices [Lantern Surgical Assistant (HSA)]

00810832031468RS LANTERN KNEE (RS20)
00810832031451Reference Sensor (RS), LSA

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