FDA.reportPublic FDA data

Bluntport Plus

Primary DI
10884521081130
Brand
Bluntport Plus
Company
Covidien LP
Model
176626P
Catalog number
176626P
Device description
Blunt Trocar
Published
2018-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903419000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903419000MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVEUnited States Surgical, A Division of Tyco Healthc1990-08-09GDH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521081130PackageGS13In Commercial Distribution
20884521081137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452108113010884521081130
2088452108113720884521081137

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic multi-instrument access port, single-useA sterile sleeve assembly made of plastic materials intended to retract a small abdominal incision to allow multiple laparoscopic instruments to pass into the abdomen at the same time during a laparoscopic procedure. It will typically have an introducer that creates the abdominal incision (but is not used in cases where the surgeon chooses to make the incision), and a valve component that maintains the pneumoperitoneum established for the surgical procedure. It allows for the introduction of multiple instruments and/or a camera port, and removal of larger specimens during minimally-invasive laparoscopic surgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter
Outer Diameter12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10884521620209Shiley18780S2017-01-06
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10884521824355McGRATHX3-003-0002021-09-01
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10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898506847549QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848232QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848249QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848287QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848294QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848317QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848324QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506850259QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848256QuinelatoSchobell Industrial LtdaGDH2022-12-16
07898506848263QuinelatoSchobell Industrial LtdaGDH2022-12-16
10603295083375SIGMADEPUY (IRELAND)GDH2018-09-24
10381780184584Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780184607Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780221128Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780363071Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-08-16
10381780405603Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-08-16
10381780403357Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403364Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403371Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403388Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403425Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403432Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780405689Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780406983Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780408598Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10649111030956Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111031045Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111031939Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111037474Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111037610Sklar®SKLAR CORPORATIONGDH2018-04-23