Ion Tomosynthesis Board

GUDID 00886874124871

NA

INTUITIVE SURGICAL, INC.

Radiological image marker, noninvasive, reusable
Primary Device ID00886874124871
NIH Device Record Keycd388085-1020-4da0-ba57-285cfbf1ca51
Commercial Distribution StatusIn Commercial Distribution
Brand NameIon Tomosynthesis Board
Version Model Number380456
Company DUNS938647021
Company NameINTUITIVE SURGICAL, 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100886874124871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (flexible or rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-19
Device Publish Date2025-11-11

Devices Manufactured by INTUITIVE SURGICAL, INC.

00886874125557 - Force Feedback2025-12-22 Force Feedback Large Needle Driver
00886874125564 - Force Feedback2025-12-22 Force Feedback Cadiere Forceps
00886874125571 - Force Feedback2025-12-22 Force Feedback Maryland Bipolar Forceps
00886874125595 - Force Feedback2025-12-22 Force Feedback ProGrasp Forceps
00886874125601 - Force Feedback2025-12-22 Force Feedback Mega SutureCut Needle Driver
00886874124871 - Ion Tomosynthesis Board2025-11-19NA
00886874124871 - Ion Tomosynthesis Board2025-11-19 NA
10886874125974 - None2025-10-01 CAUTERY SPATUAL TIP
10886874125998 - None2025-10-01 CAUTERY HOOK TIP

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