FDA.reportPublic FDA data

Endo Dissect

Primary DI
10884523000702
Brand
Endo Dissect
Company
Covidien LP
Model
174505
Device description
Dissector
Published
2018-08-10
Public version status
Update
Distribution status
Not 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
GETMOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GETMotor, Surgical Instrument, Pneumatic PoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904578000MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMPUnited States Surgical, A Division of Tyco Healthc1990-10-30GET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884523000709PackageGS16Not in Commercial Distribution
10884523000702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452300070920884523000709
1088452300070210884523000702

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic scissors, reusableA hand-held rigid device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of stainless steel and is designed as a long pair of parallel sliding arms whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a ringed handle at the proximal end. It is typically introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24
10884521211933Shiley5-182372017-05-10
10884521543799SigniaSIGPSHELL2017-08-08
10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
20884521105574Mallinckrodt5-185412015-08-28
40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809317170671LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170701LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170817LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317171012LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170657LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170664LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170695LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170824LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08800038048270LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048287LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048294LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048300LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038053151LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038055421LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055438LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055445LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055469LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08809317170800LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048645LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
08800038048652LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
08800038055452LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
06946998817265BojinShanghai Bojin Electric Instrument & Device Co., Ltd.GET2022-12-29
05051471038820De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471047631De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471085596De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471098152De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
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05051471109773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28