FDA.reportPublic FDA data

ORLocate

Primary DI
10724995220140
Brand
ORLocate
Company
STERIS CORPORATION
Model
ORLocate Towel
Catalog number
ORTW04
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
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
30724995220144PackageGS140In Commercial Distribution
15060356150141PreviousGS10
10724995220140PrimaryGS10
00724995220143Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3072499522014430724995220144
1506035615014115060356150141
1072499522014010724995220140
00724995220143007249952201437249952201430724995220143

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.

Contacts#

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

Regulatory Flags#

DUNS number
036985604
Device count
4
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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

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