FDA.reportPublic FDA data

SurgiCount

Primary DI
07613327622751
Brand
SurgiCount
Company
STRYKER CORPORATION
Model
0894000003
Catalog number
0894-000-003
Device description
+ Sponge Counting Software
Published
2024-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LWHCounter, sponge, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWHCounter, Sponge, SurgicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327622751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327622751076133276227517613327622751

GMDN Terms#

Term, Definition table
TermDefinition
Electronic surgical sponge-counterA hand-held battery-powered computerized device intended to be used in the operating room (OR) by professional staff to electronically maintain the count of surgical sponges/swabbing materials during a surgical procedure to prevent swabs from being inadvertently left in a patient. It typically has controls/keyboard, display and built-in bar-code reader, whereby packs of surgical sponges entering the surgical field are intended to be scanned in and counted out. It may include device for battery recharging or connection to a personal computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850024195028MOLLIMM10002021-08-27
00850024195134MOLLIMS-00009MM10122022-06-27
00850024195219MOLLIMP2015A2024-04-13
00850024195141MOLLIMP20012023-03-30
00850024195158MOLLIMT20012023-03-30
00850024195004MOLLIMP10012021-08-27
00850024195011MOLLIMT10012021-08-27
07613327651232SportSuite0203-10000203-10002026-08-21
07613327679410Mini-PRO Pediatric Restraint System (with Modified X-Restraints)6410055500016410055500012026-08-21
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327358308iVAS8080108000808-010-8002019-01-11
04546540434371PCD SpinePlex05055820000505-582-0002015-09-24
04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
04546540434418PCD05055870000505-587-0002015-09-24
04546540434425PCD05055890000505-589-0002015-09-24
07613327639032Broadway SystemBRW8E100D-3PK01BRW8E100D-3PK012025-03-12
07613327639049Broadway SystemBRW8E105D-3PK01BRW8E105D-3PK012025-03-12
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04

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
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
00724995220648ORLocateSteris 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