FDA.reportPublic FDA data

injeTAK Adjustable Tip Needle 70cm

Primary DI
20627825000028
Brand
injeTAK Adjustable Tip Needle 70cm
Company
Laborie Medical Technologies Canada ULC
Model
DIS201
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090830000LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPLaborie Medical Technologies, Ltd.2009-07-21FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627825000021PackageGS12In Commercial Distribution
20627825000028PackageGS150In Commercial Distribution
00627825000024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062782500002110627825000021
2062782500002820627825000028
00627825000024006278250000246278250000240627825000024

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
203383526
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627825000031Pump Tubing Infusion LineTUB5002016-09-21
00627825011013Probe, Manometry, Vaginal SensorPRB1132017-09-01
00627825011020Probe, Manometry, Anal SensorPRB1082017-09-01
00627825011037Tube for Anal Sensor, with 3-way StopcockPRB0782017-09-01
00627825011044Tube for Vaginal Sensor, with 3-way StopcockPRB0802017-09-01
00627825000109ITAITA2016-09-21
00627825008204Y-Piece9021P11642016-09-21
10627825007020Extension Set 29021P12832016-09-21
10627825007297Extension Line, 60 cm9021P63122016-09-21
10627825007310Extension Line, 1500mm9021P63322016-09-21
10627825007327Extension Line, 15cm9021P63512016-09-21
10627825007341Extension Line, 150cm Blue9021P63712016-09-21
10627825007358Extension Line, 150cm Yellow9021P63812016-09-21
10627825008294Extension Set 39021P12932016-09-21
10627825008386Extension Line, 90 cm9021P63222016-09-21
10627825008393Extension Line, 150cm Red9021P63612016-09-21
10627825010358Tubing, Extension Line, Clear, with Stopcock, 150 cmTUBEX1CS2017-10-01
10627825010365Tubing, Extension Line, Clear, 150 cmTUBEX1C2017-10-01
10627825010372Tubing, Extension Line, Blue for Pves, 150 cmTUBEX1B2017-10-01
10627825010389Tubing, Extension Line, Red for Pabd, 150 cmTUBEX1R2017-10-01

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