FDA.reportPublic FDA data

Endo Dissect

Primary DI
10884523000740
Brand
Endo Dissect
Company
Covidien LP
Model
176645
Device description
Dissector
Published
2018-08-10
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
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
20884523000747PackageGS16In Commercial Distribution
10884523000740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452300074720884523000747
1088452300074010884523000740

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26
10884521141742Endo GIAEGIARADXT2015-09-01
10884521703728Tri-Staple 2.0SIGCIR28MT2019-06-29
10884521703735Tri-Staple 2.0SIGCIR28XT2024-11-29
10884521703780Tri-Staple 2.0SIGCIR21MT2019-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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08800038048287LEOPARDIMEDICOM CO., LTD.GET2023-06-21
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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
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