FDA.reportPublic FDA data

Neptune®

Primary DI
00816849019277
Brand
Neptune®
Company
ENDOCHOICE, INC.
Model
DNX-446
Device description
25 Gauge (0.5 mm) Injection Needle
Published
2016-09-08
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
FBKEndoscopic Injection Needle, Gastroenterology-Urology

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816849019277PrimaryGS10
00816849019260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816849019277008168490192778168490192770816849019277
00816849019260008168490192608168490192600816849019260

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 Gauge25Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-632-3636customercare@endochoice.com

Regulatory Flags#

DUNS number
014154279
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840253110067Seal®SBC-5802017-11-06
00840253101068Seal®SBC-4602016-09-08
00816849010113Seal®SBC-3652016-09-08
00816849010120Seal®SBC-3662016-09-08
00840253103932FuseBoxFSP-100-ARFSP-100-AR2017-08-11
00840253104267FuseBoxLS-FSP-100LS-FSP-1002017-08-11
00840253104274FuseBoxLS-FSP-100-ARLS-FSP-100-AR2017-08-11
00840253109521Fuse®FDEMO-F75232016-09-08
00840253109538Fuse®FDEMO-F75242016-09-08
00840253109545Fuse®FDEMO-F75252016-09-08
00840253109552Fuse®FSC330-F75262016-09-08
00840253109576Fuse® FSC330-F7528FSC330-F75282016-09-08
00840253109583Fuse®FSC330-G75292016-09-08
00840253109590Fuse® FSC330-G75302016-09-08
00840253109606Fuse® FSC330-G75312016-09-08
00840253109811Fuse®FSG250-H76412016-09-08
00840253109828Fuse®FSG250-H76422016-09-08
00840253109835Fuse®FSC330-F75232016-09-08
00840253109842Fuse®FSC330-F75242016-09-08
00840253109859Fuse®FSC330-F75252016-09-08

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
00724995219215FastFloUS EndoscopyFBK2022-11-09
00724995180881NAUS EndoscopyFBK2020-04-02
00724995180898NAUS EndoscopyFBK2020-04-02
00724995180904NAUS EndoscopyFBK2020-04-02
00724995180911NAUS EndoscopyFBK2020-04-02
00724995180928NAUS EndoscopyFBK2020-04-02
00724995180935NAUS EndoscopyFBK2020-04-02
00724995180942NAUS EndoscopyFBK2020-04-02
00724995180850ArticulatorUS EndoscopyFBK2020-04-01
00724995180867ArticulatorUS EndoscopyFBK2020-04-01
00724995180874ArticulatorUS EndoscopyFBK2020-04-01
00724995180782iSnareUS EndoscopyFBK2020-03-19
00724995180799iSnareUS EndoscopyFBK2020-03-19