FDA.reportPublic FDA data

Passport SmartTip Trocar

Primary DI
00869257000306
Brand
Passport SmartTip Trocar
Company
BELLUSCURA PLC
Model
8.5mmx100mm
Catalog number
0260-285-100
Device description
THe Passport SmartTip Trocar is an access device that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures in adult and adolescent (12 to 21 years of age) populations. The Passport SmartTip Trocar is a single use disposable device, not to be resterilized.
Published
2017-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
10869257000303PackageGS16In Commercial Distribution
00869257000306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086925700030310869257000303
00869257000306008692570003068692570003060869257000306

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.

Contacts#

Phone, Email table
PhoneEmail
1-844-883-0940customerservice@belluscura.com

Regulatory Flags#

DUNS number
221297691
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
00850029991069DISCOV-R701882025-04-18
00850029991076DISCOV-R700512025-04-18
00850029991083DISCOV-R700732025-04-18
00850029991113DISCOV-R70051-US-0012025-04-18
00850029991144DISCOV-R723912025-04-18
00850029991151DISCOV-R722912025-04-18
00850029991168DISCOV-R721912025-04-18
00850029991175DISCOV-R703512025-04-18
00850029991182DISCOV-R70051-US-0022025-04-18
00850029991199DISCOV-R70051-US-0042025-04-18
00850029991243DISCOV-R70051-US-0052025-04-18
00850029991014X-PLO2R500842025-04-17
00850029991021X-PLO2R501882025-04-17
00850029991038X-PLO2R500732025-04-17
00850029991090X-PLO2R500732025-04-17
00850029991120X-PLO2R50051-US-0012025-04-17
00850029991137X-PLO2R50051-US-0022025-04-17
00850029991205X-PLO2R503512025-04-17
00850029991212X-PLO2R521912025-04-17
00850029991229X-PLO2R522912025-04-17

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Primary DI, Brand, Company table
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