FDA.reportPublic FDA data

Endoscopic Injection Needle

Primary DI
10858015005940
Brand
Endoscopic Injection Needle
Company
Carbon Medical Technologies, Inc.
Model
101087
Catalog number
101087
Device description
Endoscopic Injection Needle
Published
2017-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K172227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172227000Endoscopic Injection NeedleCarbon Medical Technologies, Inc.2017-08-23FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858015005940PackageGS15In Commercial Distribution
00858015005943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085801500594010858015005940
00858015005943008580150059438580150059430858015005943

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
Length140Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8882070262info@carbonmed.com

Regulatory Flags#

DUNS number
883094039
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850002461388InjecSURE ®890-313S890-313S2026-04-09
10850002461395InjecSURE ®890-313P890-313P2026-04-09
10850002461418InjecSURE ®890-310S890-310S2026-04-09
10850002461425InjecSURE ®890-310P890-310P2026-04-09
00850002461404InjecSURE ®890-305SS890-305SS2026-04-09
00850002461435InjecSURE®890-305PS890-305PS2026-04-09
00850002461343BiomarC®0401670401672024-07-23
00850002461350Carbon Bright ®0401660401662024-07-23
10850002461340BiomarC®0401670401672024-07-23
10850002461357Carbon Bright ®0401660401662024-07-23
00858015005646BiomarC ® 0401430401432016-10-12
00850002461046Carbon Bright®0401510401512020-01-08
00850002461053Carbon Bright®0401520401522020-01-08
00850002461060Carbon Bright ®0401530401532020-02-18
00850002461077Carbon Bright ®0401540401542020-02-18
00850002461305BIOMARC ® EX0401650401652022-02-07
00858015005059BiomarC®0401400401402015-08-07
00858015005066BiomarC ®0401010401012015-08-18
00858015005073BiomarC ®0401330401332015-08-18
00858015005080BiomarC ®0401420401422015-08-18

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