FDA.reportPublic FDA data

ORLocate

Primary DI
50724995220353
Brand
ORLocate
Company
Steris Corporation
Model
ORLocate Gauze
Catalog number
GTS0404X1210NS
Device description
ORLocate RFID Gauze, 4-inch x 4-inch, 12-ply, X-Ray, Non-sterile is used with the ORLocate Sponge Solution System.
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDYGauze/sponge, internal, x-ray detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30724995220359PackageGS114In Commercial Distribution
50724995220353PackageGS120In Commercial Distribution
10724995220355PrimaryGS10
00724995220358Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3072499522035930724995220359
5072499522035350724995220353
1072499522035510724995220355
00724995220358007249952203587249952203580724995220358

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch
Width4Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
177360039
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
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
00724995222031NATable ExtensionBF002612026-02-13
00724995222055NATable ExtensionBF002632026-02-13
00724995222062NATable ExtensionBF002642026-02-13
00724995222079NATable ExtensionBF002652026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253050293VistecCardinal Health 200, LLCGDY2026-03-05
10815555025678CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025685CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025661CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025630CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025623CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025647CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025654CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
50198956239690CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
10850049994863Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994870Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994887Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994894Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994900Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994917Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994924Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994931Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994948Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994955Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994962Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994979SynterventionZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994993Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-23
10850049994986Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-22
37613327465854SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
06979032640079GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GDY2025-08-26
30193489015991MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-12
40888277338914MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079747MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079754MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079822MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06