FDA.reportPublic FDA data

Trabectome Handpiece

Primary DI
00854028002092
Brand
Trabectome Handpiece
Company
NEOMEDIX CORPORATION
Model
550035
Catalog number
550035-01
Device description
The Trabectome Handpiece is intended to be used in electrosurgical applications in soft tissue, in general and in ophthalmic surgery. The handpiece is designed to surgically remove a strip of trabecular meshwork for surgical management of infantile and adult glaucoma. The handpiece is packaged in a surgical procedure pack containing multiple components intended to be utilized in ophthalmic surgery.
Published
2016-09-28
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
HQRApparatus, Cautery, Radiofrequency, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQRApparatus, Cautery, Radiofrequency, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040584000NMX-1000Neomedix Corp.2004-04-22GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854028002092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854028002092008540280020928540280020920854028002092

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-258-8355CustomerCare@neomedix.net

Regulatory Flags#

DUNS number
945496792
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854028002177Goniotome +I/A Handpiece550052-112019-07-17
00854028002184Goniotome Handpiece550052-15550052-152019-07-17
10854028002136Trabectome High Frequency Generator (100-240V)550050550050-012016-09-28
00854028002030Trabectome High Frequency Generator (110V)550047550047-012016-09-28
10854028002167Trabectome I/A Console (100-240V)550014-02550014-022016-09-28
00854028002023Trabectome I/A Console (110V)550014550014-012016-09-28
00854028002115Trabectome I/A Cannula550037-012019-07-17
00854028002108Trabectome Fluidics Set550034-012019-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04049539100504DIATHERMY FORCEPSCarl Zeiss Meditec AGHQR2022-04-25
00757770423606Bausch + LombBausch & Lomb IncorporatedHQR2021-05-10
00781096115747Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
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00781096115860Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
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00781096115969Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115976Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115983Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116003Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116010Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116027Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116034Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116041Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116058Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25