FDA.reportPublic FDA data

ORLocate

Primary DI
00724995220648
Brand
ORLocate
Company
Steris Corporation
Model
ORLocate Locator
Catalog number
OX202
Device description
OrLocate Locator is used with the ORLocate Sponge Solution System.
Published
2023-03-14
Public version status
Update
Distribution status
Not 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
00724995220648PreviousGS10
05060356150205PreviousGS10
00724995243647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995220648007249952206487249952206480724995220648
05060356150205050603561502055060356150205
00724995243647007249952436477249952436470724995243647

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque woven surgical spongeA non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
177360039
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995220228NAArm SupportBF4312024-01-31
00724995225148NABF00066BF000662025-03-31
00724995217280NAPowerLift PlusBF8672022-12-20
00724995225155NABF686BF6862024-04-08
10885403097836V. MuellerOP2610OP26102018-09-07
10885403099878V. MuellerOP6581OP65812019-01-02
10885403099939V. MuellerOP6975OP69752018-09-07
10885403099960V. MuellerOP6990OP69902018-09-07
10885403105395V. MuellerOS5500OS55002018-09-10
10885403111792V. MuellerRH751RH7512018-09-14
10885403112102V. MuellerRH1045RH10452018-09-10
10885403072833V. MuellerNL2750NL27502018-08-30
10885403073090V. MuellerNL3106NL31062018-08-30
10885403073113V. MuellerNL3108NL31082018-08-30
10885403113628V. MuellerRH1830RH18302018-09-10
10885403113635V. MuellerRH1860RH18602018-09-10
10885403014635V. MuellerBE400BE4002018-08-02
10885403026348V. MuellerCH2605CH26052018-08-09
00724995225117NALeg PositionerBF3512023-10-03
10885403008566V. MuellerAU5685AU56852022-11-27

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
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
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