FDA.reportPublic FDA data

"FORWARD Finger Thoracostomy Kit 8"" R-Pean, Bilateral"

Primary DI
00850056748537
Brand
"FORWARD Finger Thoracostomy Kit 8"" R-Pean, Bilateral"
Company
INTEGRATED MEDCRAFT LLC
Model
4818-32508
Device description
Convenience kit for bilateral finger thoracotomy procedure, including items for skin prep, instruments, and chest seal.
Published
2025-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray
PYIThoracic Catheter Insertion Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
PYIThoracic Catheter Insertion TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056748537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056748537008500567485378500567485370850056748537

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
107523667
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056748216FORWARD APLS Body GuardXAPLSV3378BG-12026-04-21
00850056748605EMS Chest Tube Insertion Kit, 24Fr4818-328002026-04-14
00850056748551Finger Thoracostomy Kit4818-325022026-03-03
00850056748568FORWARD® Intraosseous Infusion Bundle1011-150192026-03-02
00850056748599FORWARD® Classroom Bleeding Control Kit1011-100202026-03-02
00850056748476FORWARD Finger Thoracostomy Kit - Bilateral4818-325012025-08-22
00850056748377APLS Thermal WrapAPLSV-3378H1-42026-02-16
00850056748360APLS Thermal WrapAPLSV-3378H1-42026-02-16
00850056748292FORWARD APLS Litter GuardLGV-2272-22026-01-15
00850056748391FORWARD APLS Transport with Comfort PlusAPLSV-CP-20722025-12-30
00850056748384FORWARD APLS Transport with Comfort PlusAPLSV-CP-20722025-12-30
00850056748544FORWARD USSS Active Shooter Aid Pack (5-Pack in Duffle)USSS-ASAP-D2025-12-11
00850056748513KINGFISHER Compact Individual First Aid Kit766562025-12-05
00850056748230FORWARD APLS Emergency BlanketAPLSV-5982-EB-22025-11-25
00850056748353FORWARD APLS Thermal GuardAPLSV-3391H/3-22025-11-25
00850056748278FORWARD APLS LIFE GUARDAPLSV-3281H/6-22025-10-07
00850056748315FORWARD APLS Surgery SoakerCPV-2854-12025-11-06
00850056748520"FORWARD EMS Chest Tube Insertion Kit, 28Fr, 8"" Pean"4818-328282025-10-15
00850056748254FORWARD APLS GURNEY GUARDGG-2272CL2025-10-07
00850056748339FORWARD APLS Thermal Guard MylarAPLSV-2276H/6-22025-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233017276Busse Hospital DisposablesROBERT BUSSE & CO., INC.LRO2026-05-28
10809160522059HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522073HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522080HalyardAVID MEDICAL, INC.LRO2026-05-28
10885632522079SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-05-28
10653160393702MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-05-27
10653160393757CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-05-27
10809160521878HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521885HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521892HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521922HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521939HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521946HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521953HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521960HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521977HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521991HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522004HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522011HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522028HalyardAVID MEDICAL, INC.LRO2026-05-27
M689HHCTUINK01050Chest Tube Insertion KitSafeguard US Operating, LLCPYI2026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 5Safeguard US Operating, LLCPYI2026-05-27
H65857028265Henry ScheinHENRY SCHEIN, INC.LRO2022-01-28
H65857028255Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028285Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028905Henry ScheinHENRY SCHEIN, INC.LRO2022-01-18
H65857028875Henry ScheinHENRY SCHEIN, INC.LRO2021-12-29
H65857028865Henry ScheinHENRY SCHEIN, INC.LRO2021-12-21
H65857028855Henry ScheinHENRY SCHEIN, INC.LRO2021-12-14
H65857028845Henry ScheinHENRY SCHEIN, INC.LRO2021-12-13