ORLocate OX100

GUDID 00724995220624

ORLocate Sponge Solution is an innovative counting and locating technology that enhances patient safety and reduces time spent counting and searching for sponges in the operating room.

Steris Corporation

Radio-frequency identification reader
Primary Device ID00724995220624
NIH Device Record Key1b4ba7ca-e0fe-4e5c-b154-f8dd1b949b4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameORLocate
Version Model NumberORLocate Sponge Solution
Catalog NumberOX100
Company DUNS177360039
Company NameSteris Corporation
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995220624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWHCounter, sponge, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [ORLocate]

55060356150057ORLocate Locator Drape with three straps, non-sterile is used with the ORLocate Sponge Solution
55060356150033ORLocate HoveRead Drape with two straps, non-sterile is used with the ORLocate Sponge Solution S
55060356150019ORLocate Locator Drape with two straps, non-sterile is used with the ORLocate Sponge Solution Sy
55060356150040ORLocate Locator Drape with three straps, sterile is used with the ORLocate Sponge Solution Syst
55060356150026ORLocate HoveRead Drape with two straps, sterile is used with the ORLocate Sponge Solution Syst
55060356150002ORLocate Locator Drape with two straps, sterile is used with the ORLocate Sponge Solution System
35060356150411ORLocate RFID Gauze Lap Sponge is used with the ORLocate Sponge Solution System.
55060356150408ORLocate RFID Gauze 16-ply is used with the ORLocate Sponge Solution System.
55060356150156ORLocate RFID Vaginal Packing Loop and Fold is used with the ORLocate Sponge Solution System.
35060356150145ORLocate RFID Gauze Lap Sponge is used with the ORLocate Sponge Solution System.
55060356150071ORLocate RFID Gauze Lap Sponge is used with the ORLocate Sponge Solution System.
05060356150229OrLocate Reader Box is used with the ORLocate Sponge Solution System.
05060356150212OrLocate HoveRead is a used with the ORLocate Sponge Solution System.
05060356150205OrLocate Locator is a component to the ORLocate Sponge Solution System.
50724995221107ORLocate RFID Tonsil Sponge, Tape Strung, X-Ray, 0.875 inch diameter, Sterile is used with the O
50724995221084ORLocate RFID Tonsil Sponge, Tape Strung, X-Ray, 1-inch diameter, Sterile is used with the ORLoc
50724995221077ORLocate RFID Tonsil Sponge, Tape Strung, X-Ray, 1.25 inch diameter, Sterile is used with the OR
50724995221060ORLocate RFID Tonsil Sponge, Tape Strung, X-Ray, 1.5 inch diameter, Sterile is used with the ORL
50724995221053ORLocate RFID Tonsil Sponge, Double Strung, X-Ray, 0.875 inch diameter, Sterile is used with the
50724995221046ORLocate RFID Tonsil Sponge, Double Strung, X-Ray, 0.75 inch diameter, Sterile is used with the
50724995221039ORLocate RFID Tonsil Sponge, Double Strung, X-Ray, 1-inch diameter, Sterile is used with the ORL
50724995221015ORLocate RFID Tonsil Sponge, Double Strung, X-Ray, 1.5 inch diameter, Sterile is used with the O
30724995221004ORLocate RFID Vaginal Packing, 4-inchx18-inch, Loop, Folded, X-ray, Non-sterile is used with the
50724995220995ORLocate RFID Vaginal Packing; 4-inch x 18-inch, Loop, Folded, X-ray, Sterile is used with the O
50724995220988ORLocate RFID Vaginal Packing, 2-inch x 72-inch, Loop, Folded, X-ray, Non-sterile is used with
30724995220960ORLocate RFID OR Towel, Green, X-ray, Non-sterile is used with the ORLocate Sponge Solution Syst
50724995220957ORLocate RFID OR Towel, Green, X-ray, Sterile is used with the ORLocate Sponge Solution System.
30724995220946ORLocate RFID OR Towel, Blue, X-ray, Non-sterile is used with the ORLocate Sponge Solution Syste
50724995220933ORLocate RFID OR Towel, Blue, X-ray, Sterile is used with the ORLocate Sponge Solution System.
50724995220926ORLocate RFID Lap Sponge, 18-inch x 36-inch, X-ray, Non-sterile is used with the ORLocate Sponge
50724995220919ORLocate RFID Lap Sponge, 18-inch x 36-inch, X-ray, Sterile is used with the ORLocate Sponge Sol
50724995220902ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, Unwashed, Non-sterile is used with the ORLoc
50724995220896ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, Unwashed, Sterile is used with the ORLocate
30724995220885ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, No Loop, Non-sterile is used with the ORLoca
30724995220861ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, Non-sterile is used with the ORLocate Sponge
50724995220858ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, Sterile is used with the ORLocate Sponge Sol
50724995220841ORLocate RFID Lap Sponge, 17-inch x 26-inch, X-ray, Non-sterile is used with the ORLocate Sponge
50724995220834ORLocate RFID Lap Sponge, 17-inch x 26-inch, X-ray, Sterile is used with the ORLocate Sponge Sol
50724995220810ORLocate RFID Lap Sponge, 4-inch x 9-inch, X-ray, Sterile is used with the ORLocate Sponge Solut
30724995220809ORLocate RFID Gauze, 8-inch x 4-inch, 32-ply, X-ray, Non-sterile is used with the ORLocate Spong
50724995220797ORLocate RFID Gauze, 8-inch x 4-inch, 32-ply, X-ray, Sterile is used with the ORLocate Sponge So
30724995220786ORLocate RFID Gauze 4-inch x 4-inch, 8-ply, X-ray; Non-sterile is used with the ORLocate Sponge
50724995220773ORLocate RFID Gauze, 4-inch x 4-inch, 8-ply, X-ray, Sterile is used with the ORLocate Sponge Sol
50724995220766ORLocate RFID Gauze, 4-inch x 4-inch, 12-ply, X-ray, Sterile is used with the ORLocate Sponge So
50724995220728ORLocate RFID Gauze, 2-inch x 2-inch, 8-ply, X-ray, Sterile is used with the ORLocate Sponge Sol
50724995220711ORLocate RFID Gauze, 2-inch x 2-inch;, 12-ply, X-ray, Non-sterile is used with the ORLocate Spon
50724995220704ORLocate RFID Gauze, 2-inch x 2-inch, 12-ply, X-ray, Sterile is used with the ORLocate Sponge So
30724995220540ORLocate RFID OR Towel, White, X-Ray, Non-sterile is used with the ORLocate Sponge Solution Syst
50724995220537ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-Ray, Ring, Sterile is used with the ORLocate Spon
30724995220519ORLocate RFID Lap Sponge, 12-inch x 12-inch, X-Ray, Non-sterile is used with the ORLocate Sponge

Trademark Results [ORLocate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORLOCATE
ORLOCATE
85362637 4313783 Live/Registered
Haldor Advanced Technologies Ltd.
2011-07-04

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