Situate 01-0043

GUDID 10884521700703

Detection Console 200X

Covidien LP

Surgical sponge-counting rack
Primary Device ID10884521700703
NIH Device Record Keyb82e6fa0-e1d7-4d34-9078-f85b50ad8da3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSituate
Version Model Number01-0043
Catalog Number01-0043
Company DUNS058614483
Company NameCovidien LP
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 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

Phone+1(508)261-8000
Email[email protected]

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521700703 [Primary]

FDA Product Code

LWHCounter, sponge, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-27
Device Publish Date2018-09-26

On-Brand Devices [Situate]

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20884521709888OR Towel - RF and X-ray Detectable Green. Caution: For Manufacturing, Processing or Repacking.
20884521701066OR Towel -RF and X-ray Detectable White. Caution: For Manufacturing, Processing or Repacking.
20884521701059OR Towel -RF and X-ray Detectable Blue. Caution: For Manufacturing, Processing or Repacking.
10884521705319Delivery Console 200X
10884521705296Delivery Console 200LD-V
20884521700724Room Scanner For use with the Situate Detection Console 200X
10884521700703Detection Console 200X
10884521700666Delivery Scanner For use with Situate Delivery Console 200LD-V
10884521700659Delivery Console 200LD-V
10884521700642Body Scanner Lite For use with the Situate Detection Console 200E and Console 200X

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