FDA.reportPublic FDA data

Subcutaneous tunneller, single-use

Definition
A sterile, 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. This is a single-use device.
GUDID devices
142
Last updated
2023-08-01 08:46:04

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
50885403076051DenverCAREFUSION 2200, INC42-31002018-07-18
00350770472065CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.472062020-06-01
10680651472127Cortrak*2 Enteral Access System-Smart Receiver UnitAvanos Medical, Inc.472122017-12-14
10884521004788ArgyleMozarc Medical US LLC88884156792015-08-31
03760124131444SophysaSOPHYSATUG-452023-06-02
13760124131458SophysaSOPHYSATUG-652023-06-02
04041906507336AESCULAPAesculap AGFX001SU2023-04-03
04041906507343AESCULAPAesculap AGFX002SU2023-04-03
04041906507350AESCULAPAesculap AGFX003SU2023-04-03
04041906507367AESCULAPAesculap AGFX004SU2023-04-03
04041906507374AESCULAPAesculap AGFX005SU2023-04-03
04041906507381AESCULAPAesculap AGFX006SU2023-04-03
04041906507398AESCULAPAesculap AGFX007SU2023-04-03
04041906507404AESCULAPAesculap AGFX008SU2023-04-03
30381780033176Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9011182016-09-01
30381780033206Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9011242016-09-01
30381780034395Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9900012016-09-01
30381780034418Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9900102016-09-01
30381780034425Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9900122016-09-01
M2729MD21011Integra DP Valve SystemINTEGRA NEUROSCIENCES IMPLANT (FRANCE)9MD21012015-10-01
M2729MD21021Integra DP Valve SystemINTEGRA NEUROSCIENCES IMPLANT (FRANCE)9MD21022015-10-01
M272VK521Licox ®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)VK522016-08-04
10681490078013NAMEDTRONIC, INC.3550-062014-09-23
00763000571092N/AMEDTRONIC, INC.3755-402022-06-04
10866614000181Subcutaneous Guidewire - MediumARKIS BIOSCIENCES INC.41.240.5022018-12-14
10866614000198Subcutaneous Guidewire - LargeARKIS BIOSCIENCES INC.41.240.5032018-12-14
09352307000131Evoke® Tunnelling ToolSALUDA MEDICAL PTY LIMITED30122022-03-15
10886704041306CODMAN MEDOSCerenovus, Inc.82-30552015-09-20
20886704040405CODMANCODMAN & SHURTLEFF, INC.82-15152015-09-20
30886704040419CODMANCODMAN & SHURTLEFF, INC.82-15162015-09-20
30886704040426CODMANCODMAN & SHURTLEFF, INC.82-15172015-09-20
10886704028468CODMANCerenovus, Inc.60-29202016-06-30
00763000306687DBS™MEDTRONIC, INC.37552021-05-31
00763000082956NAMEDTRONIC, INC.3655P382021-03-25
20643169646326NAMEDTRONIC, INC.6212-S52021-02-06
05391527772415Mainstay TunnelerMAINSTAY MEDICAL LIMITED7MTUN1-0022021-01-25
30381780072366Integra Disposable Peritoneal Catheter PasserIntegra Lifesciences CorporationNL85020012015-09-22
30381780072373Integra Disposable Peritoneal Catheter PasserIntegra Lifesciences CorporationNL85020022015-09-22
10193494135765AVANOSAvanos Medical, Inc.135762020-07-03
10193494135819AVANOSAvanos Medical, Inc.135812020-07-03
10193494135833AVANOSAvanos Medical, Inc.135832020-07-03
10193494136922AVANOSAvanos Medical, Inc.136922020-07-03
10193494136939AVANOSAvanos Medical, Inc.136932020-07-03
10193494136946AVANOSAvanos Medical, Inc.136942020-07-03
10193494136953AVANOSAvanos Medical, Inc.136952020-07-03
10193494136960AVANOSAvanos Medical, Inc.136962020-07-03
10193494136977AVANOSAvanos Medical, Inc.136972020-07-03
00382830058186Natus®NATUS MEDICAL INCORPORATEDNT8502002 2020-04-17
00382830058193Natus®NATUS MEDICAL INCORPORATEDNT8502001 2020-04-17
50884908144678N/AMedical Components, Inc.DMC3B2019-08-28
50884908145620NANAMedical Components, Inc.DAST2019-08-10
50884908145644N/AN/AMedical Components, Inc.DBTH2019-08-10
50884908145675N/AN/AMedical Components, Inc.DCTT2019-08-10
50884908145682N/AN/AMedical Components, Inc.DHFT2019-08-10
50884908145699NANAMedical Components, Inc.DAST-L2019-08-10
50884908145705N/AN/AMedical Components, Inc.DFSX2019-08-10
50884908146733N/AN/AMedical Components, Inc.DASTSG2019-08-10
00382830055246Natus®NATUS MEDICAL INCORPORATEDNT9900102020-04-03
00382830055420Natus®NATUS MEDICAL INCORPORATEDNT9MD12412020-04-03
00382830055468Natus®NATUS MEDICAL INCORPORATEDNT9900012020-04-03
00382830057363Natus®NATUS MEDICAL INCORPORATEDNT9011182020-04-03
00382830057370Natus®NATUS MEDICAL INCORPORATEDNT9011242020-04-03
00382830057431Natus®NATUS MEDICAL INCORPORATEDNT9900122020-04-03
00763000027841Catheter PasserMEDTRONIC PS MEDICAL, INC.484092020-04-03
00813426020411NevroNEVRO CORP.ACCK21002020-01-11
10381780515487CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION8215152020-04-01
10381780515494CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION8215162020-04-01
10381780515500CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION8215172020-04-01
00381780521405CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION83-13252020-04-01
00381780521412CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION83-13262020-04-01
00763000031404Catheter PasserMEDTRONIC PS MEDICAL, INC.8591-382020-01-27
00763000031411Catheter PasserMEDTRONIC PS MEDICAL, INC.8591-602020-01-27
50884908028862N/AMedical Components, Inc.MC3B2019-07-16
04041906131975AESCULAPAesculap AGFV002R2019-06-23
04041906131982AESCULAPAesculap AGFV003R2019-06-23
04041906131999AESCULAPAesculap AGFV004R2019-06-23
30705036001991FLEXIPATHETHICON ENDO-SURGERY, LLCFPK022016-07-15
30705036011907FLEXIPATHETHICON ENDO-SURGERY, LLCFP0072016-07-15
30705036011914FLEXIPATHETHICON ENDO-SURGERY, LLCFP0152016-07-15
30705036011921FLEXIPATHETHICON ENDO-SURGERY, LLCFP0202016-07-15