FDA.reportPublic FDA data

Bladeless Trocar - Artemis Lap™ Cannula. Cannula Ø12x100mm

Primary DI
10818674029596
Brand
Bladeless Trocar - Artemis Lap™ Cannula. Cannula Ø12x100mm
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
156210et
Catalog number
156210et
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818674029596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081867402959610818674029596

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810128462782StayPort™ Cannula 5 mm x 7 cmAR-6593-05-07159570ar2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmAR-6593-05-09159590ar2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmAR-6593-07-07159770ar2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmAR-6593-07-09159790ar2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmAR-6593-09-07159970ar2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmAR-6593-09-09159990ar2026-07-16
10810128462843StayPort™ Cannula 9 mm x 11 cmAR-6593-09-11159110ar2026-07-16
10810128462850StayPort™ Cannula 9 mm x 13 cmAR-6593-09-13159130ar2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant System3910-700-010505100st2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and Inserter3910-700-011505101st2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mm3910-700-012505102st2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mm3910-700-013505103st2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, Long3910-700-020505200st2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, Long3910-700-021505201st2026-07-16
10810128462928VersiTILT Button, 2.4x12mm3910-700-023505203st2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XL3910-700-030505300st2026-07-16
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XL3910-700-031505301st2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mm3910-700-032505302st2026-07-16
10810128462966VersiTILT Button, 3.1x10.9mm3910-700-033505303st2026-07-16
10818674027097FiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire®AR-4580176200ar2023-09-27

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