111619

GUDID 30848486016822

Silicone Retractor Cord

MAKO SURGICAL CORP.

Surgical support tape, non-bioabsorbable
Primary Device ID30848486016822
NIH Device Record Keyd8da908e-4fd9-4821-8ab3-44b8544278e3
Commercial Distribution StatusIn Commercial Distribution
Version Model Number111619
Catalog Number111619
Company DUNS175239677
Company NameMAKO SURGICAL CORP.
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 Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848486016821 [Primary]
GS130848486016822 [Package]
Contains: 00848486016821
Package: pack [10 Units]
In Commercial Distribution

FDA Product Code

GADRETRACTOR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-10
Device Publish Date2016-09-24

Devices Manufactured by MAKO SURGICAL CORP.

07613327599985 - Mako2023-07-31
07613327600001 - Mako2023-07-31
07613327600063 - Mako2023-07-31
07613327600070 - Mako2023-07-31
07613327601008 - Mako2023-07-31
00848486022747 - Calibration End Effector Inverted2022-10-13 Calibration End Effector Inverted
07613327395341 - Mako2021-04-07
07613327395280 - NA2020-12-23

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