FDA.reportPublic FDA data

ORLocate

Primary DI
00724995245290
Brand
ORLocate
Company
STERIS CORPORATION
Model
ORLocate Components Pack
Catalog number
ORL10017049
Device description
The ORLocate Components Pack contains the ORLocate Locator, ORLocate HoveRead, ORLocate Reader Box, and Advantech Medical Panel PC used with the ORLocate Sponge System.
Published
2025-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWHCounter, sponge, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWHCounter, Sponge, SurgicalGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100551000ORLOCATE SYSTEM MODEL ORL 100Haldor Advanced Technologies, Ltd.2010-08-12LWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995220631PreviousGS10
00724995245290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995220631007249952206317249952206310724995220631
00724995245290007249952452907249952452900724995245290

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency identification readerAn electronic device designed to read information stored on radio-frequency identification (RFID) tags within its read range, typically to identify and track medical devices. The reader may be of the passive (receives data only) or active (transmits and receives data) type, and may have the capability of storing and/or transmitting the read data.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
036985604
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995243647ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243661ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243630ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243654ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243678ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243685ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243692ORLocateSTERIS CORPORATIONLWH2025-04-17
10884521700710SituateCovidien LPLWH2025-04-04
10884521705265RF AssureCovidien LPLWH2025-03-31
10884521705272SituateCovidien LPLWH2024-06-10
07613327625882SurgiCountSTRYKER CORPORATIONLWH2024-02-12
07613327622751SurgiCountSTRYKER CORPORATIONLWH2024-02-09
07613327622799SurgiCountSTRYKER CORPORATIONLWH2024-02-09
07613327623079SurgiCountSTRYKER CORPORATIONLWH2024-02-09
00724995230050ORLocateSteris CorporationLWH2024-01-31
10884521816770SituateCovidien LPLWH2023-07-09
00810132041532HCSConcordance Healthcare Solutions LLCLWH2023-06-23
10810132041539HCSConcordance Healthcare Solutions LLCLWH2023-06-23
10884521780040SituateCovidien LPLWH2023-03-18
00724995220655ORLocateSteris CorporationLWH2023-03-14
00724995220648ORLocateSteris CorporationLWH2023-03-14
00724995220662ORLocateSteris CorporationLWH2023-03-14
10080196416097MEDLINEMEDLINE INDUSTRIES, INC.LWH2022-12-29
00724995220631ORLocateSteris CorporationLWH2022-12-08
00724995221683ORLocateSteris CorporationLWH2022-12-08
00724995220624ORLocateSteris CorporationLWH2022-12-07
00724995220679ORLocateSteris CorporationLWH2022-12-07
05060356150205ORLocateSteris CorporationLWH2022-11-07
05060356150212ORLocateSteris CorporationLWH2022-11-07
05060356150229ORLocateSteris CorporationLWH2022-11-07