FDA.reportPublic FDA data

Subcutaneous tunneller, single-use

Definition
A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.
GUDID devices
160
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00193494135430AVANOSAvanos Medical, Inc.135432020-06-10
00193494135447AVANOSAvanos Medical, Inc.135442020-06-10
00193494135454AVANOSAvanos Medical, Inc.135452020-06-10
00193494135461AVANOSAvanos Medical, Inc.135462020-06-10
00193494135768AVANOSAvanos Medical, Inc.135762020-07-03
00193494135812AVANOSAvanos Medical, Inc.135812020-07-03
00193494135836AVANOSAvanos Medical, Inc.135832020-07-03
00193494136925AVANOSAvanos Medical, Inc.136922020-07-03
00193494136932AVANOSAvanos Medical, Inc.136932020-07-03
00193494136949AVANOSAvanos Medical, Inc.136942020-07-03
00193494136956AVANOSAvanos Medical, Inc.136952020-07-03
00193494136963AVANOSAvanos Medical, Inc.136962020-07-03
00193494136970AVANOSAvanos Medical, Inc.136972020-07-03
00193494137342AVANOSAvanos Medical, Inc.137342020-06-10
00193494137359AVANOSAvanos Medical, Inc.137352020-06-10
00193494137366AVANOSAvanos Medical, Inc.137362020-06-10
00193494137380AVANOSAvanos Medical, Inc.137382020-06-10
00193494137397AVANOSAvanos Medical, Inc.137392020-06-10
00193494309992AVANOSAvanos Medical, Inc.309992020-06-10
00193494310004AVANOSAvanos Medical, Inc.310002020-06-10
00193494327712PROLONG* Continuous Nerve Block SetAvanos Medical, Inc.327712020-07-03
00193494327729PROLONG* Continuous Nerve Block SetAvanos Medical, Inc.327722020-07-03
00193494327750PROLONG* Continuous Nerve Block SetAvanos Medical, Inc.327752020-07-03
00350770456188CORTRAK* Enteral Access SystemAvanos Medical, Inc.20-09112020-09-25
00350770456409CORTRAK* Enteral Access SystemAvanos Medical, Inc.20-09302020-09-25
00382830053624Natus®NATUS MEDICAL INCORPORATEDNT9011242020-04-03
00382830054119Natus®NATUS MEDICAL INCORPORATEDNT9011182020-04-03
00382830055208Natus®NATUS MEDICAL INCORPORATEDNT9900122020-04-03
00382830057325Natus®NATUS MEDICAL INCORPORATEDNT8502001 2020-04-17
00382830057332Natus®NATUS MEDICAL INCORPORATEDNT8502002 2020-04-17
00382830058124Natus®NATUS MEDICAL INCORPORATEDNT9900012020-04-03
00382830058131Natus®NATUS MEDICAL INCORPORATEDNT9900102020-04-03
00382830058179Natus®NATUS MEDICAL INCORPORATEDNT9MD12412020-04-03
00643169646322NAMEDTRONIC, INC.6212-S52021-02-06
00801741085468Blunt Tip TunnellerBard Access Systems, Inc.55850002016-09-16
00801741085475TunnelerBard Access Systems, Inc.56880002016-09-16
00857595005022ambITSUMMIT MEDICAL PRODUCTS, INC.2204182016-09-09
00884908004496TROCARTROCARMedical Components, Inc.AST2018-06-29
00884908004502TROCARTROCARMedical Components, Inc.ASTSG2018-10-30
00884908005363TROCARTROCARMedical Components, Inc.BTH2016-10-21
00884908008630TROCARMedical Components, Inc.CTT2016-10-21
00884908016840TROCARTROCARMedical Components, Inc.FTT102016-10-21
00884908017656TROCARTROCARMedical Components, Inc.HFT2016-10-21
00884908028867N/AMedical Components, Inc.MC3B2019-07-16
00884908108194TROCARTROCARMedical Components, Inc.FSX2016-10-07
00884908144673N/AMedical Components, Inc.DMC3B2019-08-28
00884908145625NANAMedical Components, Inc.DAST2019-08-10
00884908145649N/AN/AMedical Components, Inc.DBTH2019-08-10
00884908145670N/AN/AMedical Components, Inc.DCTT2019-08-10
00884908145687N/AN/AMedical Components, Inc.DHFT2019-08-10
00884908145694NANAMedical Components, Inc.DAST-L2019-08-10
00884908145700N/AN/AMedical Components, Inc.DFSX2019-08-10
00884908146738N/AN/AMedical Components, Inc.DASTSG2019-08-10
03760124131451SophysaSOPHYSATUG-652023-06-02
04041906505530AESCULAPAesculap AGFX001SU2023-04-03
04041906505547AESCULAPAesculap AGFX002SU2023-04-03
04041906505554AESCULAPAesculap AGFX003SU2023-04-03
04041906505561AESCULAPAesculap AGFX004SU2023-04-03
04041906505578AESCULAPAesculap AGFX005SU2023-04-03
04041906505585AESCULAPAesculap AGFX006SU2023-04-03
04041906505592AESCULAPAesculap AGFX007SU2023-04-03
04041906505608AESCULAPAesculap AGFX008SU2023-04-03
08809317177915SPINAUT-IxIMEDICOM CO., LTD.IX10002018-06-30
08809317177922SPINAUT-IxIMEDICOM CO., LTD.IX20002018-07-13
10381780033172Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9011182016-09-01
10381780033202Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9011242016-09-01
10381780034391Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9900012016-09-01
10381780034414Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9900102016-09-01
10381780034421Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9900122016-09-01
10381780035725Integra DP Valve SystemINTEGRA NEUROSCIENCES IMPLANT (FRANCE)9MD21012015-10-01
10381780035732Integra DP Valve SystemINTEGRA NEUROSCIENCES IMPLANT (FRANCE)9MD21022015-10-01
10381780041436Licox®GMS, Gesellschaft für medizinische Sondentechnik mbHVK522015-10-01
10381780072362Integra®Integra Lifesciences CorporationNL85020012015-09-22
10381780072379Integra®Integra Lifesciences CorporationNL85020022015-09-22
10381780250371Licox ®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)VK522016-08-04
10381780509165Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION20-10382018-10-23
10381780518884CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION8230552020-06-02
10381780521402CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION8313252020-04-01
10381780521419CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION8313262020-04-01
10381780537403CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION8313252024-05-29