AS-00005787

GUDID 08885014610245

BIOBOT SURGICAL PTE. LTD.

Needle guide, single-use
Primary Device ID08885014610245
NIH Device Record Key875dfcb3-b6ce-437f-86b7-8d00d422fd84
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberiSR'obot Kit - 18G
Catalog NumberAS-00005787
Company DUNS595137775
Company NameBIOBOT SURGICAL PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108885014610245 [Primary]

FDA Product Code

OIJBiopsy Needle Guide Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-08
Device Publish Date2024-02-29

Devices Manufactured by BIOBOT SURGICAL PTE. LTD.

08885014610023 - iSR'obot Biopsy Kit2024-06-24
08885014610184 - iSR'obot Kit2024-06-24
08885014610207 - iSR'obot Kit2024-06-24
08885014610221 - iSR'obot Kit2024-06-24
08885014610245 - NA2024-03-08
08885014610245 - NA2024-03-08
08885014610382 - NA2024-03-08

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