FDA.reportPublic FDA data

GenCut

Primary DI
10884521539716
Brand
GenCut
Company
Covidien LP
Model
SDCT01
Device description
Core Biopsy System
Published
2016-09-24
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
EOQBRONCHOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142839000GenCut Core Biopsy SystemCovidien, LLC2015-04-29EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521539716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452153971610884521539716

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep dry;

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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10884521840140TrexonCY883P2026-10-10
10884521840171TrexonCY953P2026-10-10
10884521840195TrexonGY123P2026-10-10
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10884521840263TrexonSY823P2026-10-10
10884521840270TrexonSY923P2026-10-10
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10884521840447TrexonSY5638P2026-10-10

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Primary DI, Brand, Company table
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