FDA.reportPublic FDA data

Medical Action Industries

Primary DI
20809160023195
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
3230
Device description
Bag: Sponge Ct 10.25X32 2.0ml Blu 250/cs
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
30809160023192PackageGS15In Commercial Distribution
20809160023195PrimaryGS10
10809160023198Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3080916002319230809160023192
2080916002319520809160023195
1080916002319810809160023198

GMDN Terms#

Term, Definition table
TermDefinition
Surgical sponge-counting rackA device in the form of a vertically-mounted rack intended to be used in the operating room (OR) to maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a rack/holder with hooks/pockets upon which soiled sponges/swabs may be arranged; it may be used in conjunction with an associated counting bag (not included). This is a reusable device.

Regulatory Flags#

DUNS number
092364462
Device count
50
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160536506HalyardLLOG1000-182026-09-18
10809160536544HalyardSHSD015-042026-09-18
10809160536612HalyardWBAM068-042026-09-18
10809160536629HalyardSLAK19-042026-09-18
10809160536667HalyardSWDS001-022026-09-18
10809160536674HalyardLOUS019-162026-09-18
10809160536681HalyardLCNW001-122026-09-18
10809160536728HalyardSHAN453-052026-09-18
10809160536735HalyardLCNW002-032026-09-18
10809160536742HalyardFLDR004-022026-09-18
10809160536759HalyardLIFE0070-082026-09-18
10809160536766HalyardLOUS018-022026-09-18
10809160536773HalyardRDLD033-062026-09-18
10809160536797HalyardMSMT46-062026-09-18
10809160536803HalyardHVMC003-042026-09-18
10809160536810HalyardKRIV26-032026-09-18
10809160536827HalyardMETC002-042026-09-18
10809160536834HalyardLAKC032-022026-09-18
10809160536841HalyardRDLD039-102026-09-18
10809160536858HalyardONEL038-022026-09-18

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
07613327622751SurgiCountSTRYKER CORPORATIONLWH2024-02-09
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