FDA.reportPublic FDA data

ORLocate

Primary DI
15060356150059
Brand
ORLocate
Company
Steris Corporation
Model
ORLocate Drape
Catalog number
LC16961NS
Device description
ORLocate Locator Drape with three straps, non-sterile is used with the ORLocate Sponge Solution System.
Published
2022-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55060356150057PackageGS110Not in Commercial Distribution
15060356150059PrimaryGS10
05060356150052Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5506035615005755060356150057
1506035615005915060356150059
05060356150052050603561500525060356150052

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
177360039
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995153724AmscoWarming CabinetDJ0301441312026-02-13
00724995153731AmscoWarming CabinetDJ04014431112026-02-13
00724995153748AmscoWarming CabinetDJ0401443312026-02-13
00724995153755AmscoWarming CabinetDJ0501441322026-02-13
00724995153762AmscoWarming CabinetDJ0501443322026-02-13
00724995153786AmscoWarming CabinetDJ0601441312026-02-13
00724995153793AmscoWarming CabinetDJ06014431132026-02-13
00724995153809AmscoWarming CabinetDJ0601443312026-02-13
00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
10885403015960V. MuellerBP0-1ABP01A2017-11-17
10885403015977V. MuellerBP0-2ABP02A2017-11-17
10885403015991V. MuellerBP0-2VBP02V2017-11-17
10885403016004V. MuellerBP1-1ASBP11AS2017-11-17
10885403016011V. MuellerBP1-2ABP12A2017-11-17
10885403016035V. MuellerBP1-2ASBP12AS2017-11-17
10885403016066V. MuellerBP1-2VBP12V2017-11-17
10885403016073V. MuellerBP1-2VSBP12VS2017-11-17
10885403016080V. MuellerBP1-3ABP13A2017-11-17
10885403016103V. MuellerBP1-3VBP13V2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16931918101774AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918103037AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918141121AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918145204AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918183800InvenioGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
30193489017742MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017759MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017766MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017773MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017780MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017797MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
00380657530021ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
00380659983313ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
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10198956353954CARDINAL HEALTHCardinal Health 200, LLCPUI2026-07-20
20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
30193489028199MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
16931918102214AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918102948AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918107356AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
20193489108214MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
20888277636559MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
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10304040193362Henry ScheinHENRY SCHEIN, INC.PUI2026-06-25
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08