FDA.reportPublic FDA data

ORLocate

Primary DI
10724995220126
Brand
ORLocate
Company
STERIS CORPORATION
Model
ORLocate Lap Sponge
Catalog number
LTS1818X45
Device description
ORLocate RFID Gauze Lap Sponge is used with the ORLocate Sponge Solution System.
Published
2023-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDYGauze/sponge, internal, x-ray detectable
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995220124PackageGS140In Commercial Distribution
15060356150073PreviousGS10
10724995220126PrimaryGS10
00724995220129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499522012450724995220124
1506035615007315060356150073
1072499522012610724995220126
00724995220129007249952201297249952201290724995220129

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
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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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

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