FDA.reportPublic FDA data

ORLocate

Primary DI
00724995243692
Brand
ORLocate
Company
STERIS CORPORATION
Model
ORLocate Tablet
Catalog number
OX216
Device description
Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution 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
00724995220679PreviousGS10
00724995243692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995220679007249952206797249952206790724995220679
00724995243692007249952436927249952436920724995243692

GMDN Terms#

Term, Definition table
TermDefinition
Electronic surgical sponge-counterA hand-held battery-powered computerized device intended to be used in the operating room (OR) by professional staff to electronically maintain the count of surgical sponges/swabbing materials during a surgical procedure to prevent swabs from being inadvertently left in a patient. It typically has controls/keyboard, display and built-in bar-code reader, whereby packs of surgical sponges entering the surgical field are intended to be scanned in and counted out. It may include device for battery recharging or connection to a personal computer.

Sterilization Methods#

Method table
Method

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
00724995239909V. MuellerDP11DP112026-10-15
00724995239916V. MuellerDP12DP122026-10-15
00724995239923V. MuellerDP13DP132026-10-15
00724995239930V. MuellerDP14DP142026-10-15
00724995239947V. MuellerDP15DP152026-10-15
00724995239985V. MuellerED112ED1122026-10-15
00724995239992V. MuellerED15ED152026-10-15
00724995240004V. MuellerED16ED162026-10-15
00724995240011V. MuellerED17ED172026-10-15
00724995240028V. MuellerED19ED192026-10-15
00724995240660V. MuellerPP11PP112026-10-15
00724995240677V. MuellerPP12PP122026-10-15
00724995240684V. MuellerPP125PP1252026-10-15
00724995240691V. MuellerPP13PP132026-10-15
00724995240707V. MuellerPP14PP142026-10-15
00724995241025V. MuellerR1051R10512026-10-15
00724995241049V. MuellerR1065R10652026-10-15
00724995241056V. MuellerR1067R10672026-10-15
00724995241063V. MuellerR1069R10692026-10-15
00724995241070V. MuellerR1072R10722026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995243647ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243661ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995245290ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243630ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243654ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243678ORLocateSTERIS CORPORATIONLWH2025-04-17
00724995243685ORLocateSTERIS 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