FDA.reportPublic FDA data

Alton

Primary DI
06974296707322
Brand
Alton
Company
Alton (Shanghai) Medical Instruments Co., Ltd.
Model
AF-D2418NJ2305
Published
2025-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
06974296707322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974296707322069742967073226974296707322

GMDN Terms#

Term, Definition table
TermDefinition
Submucosal injection needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomical structures with lumens. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527128502
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970671381569AltonAF-D2423BZC2026-03-23
06974296705915AltonAF-D2416NJ19042026-01-26
06974296706004AltonAF-D2423NJ19042026-01-26
06974296706479AltonAF-D2416NJ21042026-01-26
06974296707131AltonAF-D2423NJ21042026-01-26
06974296707285AltonAF-D2416NJ23042026-01-26
06974296707377AltonAF-D2423NJ23042026-01-26
06975543351923AltonAF-D2418JZR-52026-01-26
06975543351947AltonAF-D2418JZR-92026-01-26
06975543352005AltonAF-D2423JZR-52026-01-26
06975543352029AltonAF-D2423JZR-92026-01-26
06974296707315AltonAF-D2418NJ23042025-12-29
06974296707339AltonAF-D2418NJ23062025-12-29
06974296707346AltonAF-D2421NJ23042025-12-29
06974296707353AltonAF-D2421NJ23052025-12-29
06974296707360AltonAF-D2421NJ23062025-12-29
06975543351916AltonAF-D2418JZR-32025-12-29
06975543351930AltonAF-D2418JZR-72025-12-29
06975543351992AltonAF-D2423JZR-32025-12-29
06975543352012AltonAF-D2423JZR-72025-12-29

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