FDA.reportPublic FDA data

Rigid Endoscopic Needle

Primary DI
08717591240280
Brand
Rigid Endoscopic Needle
Company
Uroplasty, Inc.
Model
MRN-420
Catalog number
MRN-420
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBKEndoscopic Injection Needle, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121337000UROPLASTY RIGID ENDOSCPIC NEEDLESUroplasty, Inc.2012-08-03FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717591240280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717591240280087175912402808717591240280

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge20Gauge

Contacts#

Phone, Email table
PhoneEmail
866-258-2182info.usa@cogentixmedical.com

Regulatory Flags#

DUNS number
804002665
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717591240167Urgent® PC Neuromodulation SystemUPC 250UPC 2502016-09-19
08717591240228Urgent® PC Neuromodulation SystemUPC 200UPC 2002016-09-19
08717591240266Macroplastique ImplantsMPQ-2.5MPQ-2.52014-06-20
08717591240273Rigid Endoscopic NeedleMRN-518MRN-5182016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850002461388InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461395InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461418InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461425InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
00850002461404InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
00850002461435InjecSURE®Carbon Medical Technologies, Inc.FBK2026-04-09
03600040326893BoNeeColoplast A/SFBK2025-05-20
03600040974841BoNeeColoplast A/SFBK2025-05-20
00816734023365EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023372EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023389EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023396EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816207021256AcuJect FlexENDO-THERAPEUTICS, INC.FBK2023-07-11
00860008483720Uro-N CystoscopeUROVIU CORP.FBK2022-12-16
00724995219185FastFloUS EndoscopyFBK2022-11-09
00724995219192FastFloUS EndoscopyFBK2022-11-09
00724995219208FastFloUS EndoscopyFBK2022-11-09
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00724995180935NAUS EndoscopyFBK2020-04-02
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00724995180850ArticulatorUS EndoscopyFBK2020-04-01
00724995180867ArticulatorUS EndoscopyFBK2020-04-01
00724995180874ArticulatorUS EndoscopyFBK2020-04-01
00724995180782iSnareUS EndoscopyFBK2020-03-19
00724995180799iSnareUS EndoscopyFBK2020-03-19