FDA.reportPublic FDA data

Subcutaneous tunneller, reusable

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, retinal chip). 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 reusable device intended to be sterilized prior to use.
GUDID devices
103
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190776421007MillenniumAvalign Technologies, Inc.72-251011SM662026-04-30
00198506082290ELMED INCORPORATEDELMED INCORPORATED25-1011SM-612025-10-02
00382830054140Natus®NATUS MEDICAL INCORPORATEDNT9MD1702020-04-03
10381780033301Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9012122016-08-12
10381780033318Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9012182016-08-12
10381780033325Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9012242016-08-12
10381780035749Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9MD2702016-08-12
10381780191018Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATION3055002018-03-02
10381780191025Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATION3055012018-03-02
10381780457862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATION3054982018-03-02
10381780457879Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATION3054992018-03-02
10381780540618CODMAN® HOLTER®INTEGRA LIFESCIENCES PRODUCTION CORPORATION8216902026-04-15
10381780540625CODMAN® HOLTER® SALMONINTEGRA LIFESCIENCES PRODUCTION CORPORATION8216922026-04-15
14026704795670PILLINGTELEFLEX INCORPORATEDIPN0188752022-12-08
14026704795694PILLINGTELEFLEX INCORPORATEDIPN0188772022-12-08
54026704795678PILLINGTELEFLEX INCORPORATEDIPN0188752022-12-08
14026704795700PILLINGTELEFLEX INCORPORATEDIPN0188792022-12-08
00190776410841MillenniumAvalign Technologies, Inc.72-251011312025-09-12
00190776410858MillenniumAvalign Technologies, Inc.72-251011712025-09-12
00190776401900MillenniumAvalign Technologies, Inc.72-231716702025-06-16
00198506082917ELMED INCORPORATEDELMED INCORPORATED23-1011SM-70-SH2025-05-22
00190776395957MillenniumAvalign Technologies, Inc.72-251011462025-05-09
00198506081958ELMED INCORPORATEDELMED INCORPORATED25-1011SM-602025-04-07
14026704795687PILLINGTELEFLEX INCORPORATEDIPN0188762022-12-08
00190776389215MillenniumAvalign Technologies, Inc.72-231716752024-11-15
00842180199415ELMEDELMED INCORPORATEDST251011SM312024-04-23
00842180199422ELMEDELMED INCORPORATEDST251011SM642024-04-23
00842180199439ELMEDELMED INCORPORATEDST251011SM652024-04-23
00842180199446ELMEDELMED INCORPORATEDST251011SM662024-04-23
00842180199453ELMEDELMED INCORPORATEDST251011SM702024-04-23
00842180192096ELMEDELMED INCORPORATED25-1011SM-182024-04-16
00842180192102ELMEDELMED INCORPORATED25-1011SM-252024-04-16
04041906131968AESCULAPAesculap AGFV001R2024-01-15
54026704795692PILLINGTELEFLEX INCORPORATEDIPN0188772022-12-08
G586C6610040Novo SurgicalNOVO SURGICAL, INC.C6610-042023-12-18
G586C6610060Novo SurgicalNOVO SURGICAL, INC.C6610-062023-12-18
G586C6665000Novo SurgicalNOVO SURGICAL, INC.C6665-002023-12-18
00190776299484MillenniumAvalign Technologies, Inc.72-TUN32MNH2023-11-15
00190776299880MillenniumAvalign Technologies, Inc.72-231716802023-11-15
00190776300630MillenniumAvalign Technologies, Inc.72-TUN452023-11-15
00190776301088MillenniumAvalign Technologies, Inc.72-251011612023-11-15
00190776290498MILLENNIUMAvalign Technologies, Inc.9-656050012023-09-28
00190776334734MILLENNIUMAvalign Technologies, Inc.10-3054982023-09-28
00190776370060MILLENNIUMAvalign Technologies, Inc.12-6780042023-09-28
00190776376123MillenniumAvalign Technologies, Inc.72-23171698012023-09-08
00842180175624ELMEDELMED INCORPORATED25-1011SM-702023-08-08
00842180175631ELMEDELMED INCORPORATED25-1011SM-312023-08-08
03760124131468SophysaSOPHYSATUN-452023-06-02
03760124131475SophysaSOPHYSATUN-652023-06-02
00190776373009MillenniumAvalign Technologies, Inc.72-231716982023-05-09
00842180164826ELMEDELMED INCORPORATED25-1011SM-642023-03-10
00842180164833ELMEDELMED INCORPORATED25-1011SM-662023-03-10
00842180161221ELMEDELMED INCORPORATED25-1011SM-652023-02-10
M2729012121Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9012122016-08-12
M2729012181Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9012182016-08-12
M2729012241Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9012242016-08-12
M2729MD2701Integra®INTEGRA NEUROSCIENCES IMPLANT (FRANCE)9MD2702016-08-12
00190776055837AvalignAvalign Technologies, Inc.VM77-26612021-11-03
00190776055844AvalignAvalign Technologies, Inc.VM77-266112021-11-03
00190776055868AvalignAvalign Technologies, Inc.VM77-26622021-11-03
00190776055875AvalignAvalign Technologies, Inc.VM77-26652021-11-03
00190776055882AvalignAvalign Technologies, Inc.VM77-26642021-11-03
00190776198886MillenniumAvalign Technologies, Inc.72-2485020802021-11-02
00190776209780MillenniumAvalign Technologies, Inc.72-251011SM102021-11-02
00190776209797MillenniumAvalign Technologies, Inc.72-TUN322021-11-02
10886704040705CODMAN HOLTERCerenovus, Inc.82-16902015-09-20
10886704040712CODMAN HOLTERCerenovus, Inc.82-16922015-09-20
10886704040729CODMAN HOLTERCerenovus, Inc.82-16932015-09-20
10886704040835CODMANCerenovus, Inc.82-17152015-09-20
10886704040842CODMANCerenovus, Inc.82-17162015-09-20
00190660111786Ambler SurgicalAMBLER SURGICAL CORP.Rumel tourniquet2021-01-07
00190660111793Ambler SurgicalAMBLER SURGICAL CORP.Rumel tourniquet2021-01-07
00190660111809Ambler SurgicalAMBLER SURGICAL CORP.Rumel tourniquet2021-01-07
00190660111816Ambler SurgicalAMBLER SURGICAL CORP.Rumel tourniquet2021-01-07
00190660111823Ambler SurgicalAMBLER SURGICAL CORP.Rumel tourniquet2021-01-07
00190660111830Ambler SurgicalAMBLER SURGICAL CORP.Rumel tourniquet2021-01-07
00190660111847Ambler SurgicalAMBLER SURGICAL CORP.Rumel tourniquet2021-01-07
00190660111854Ambler SurgicalAMBLER SURGICAL CORP.Rumel tourniquet2021-01-07
04038653029907AESCULAPAesculap AGBN945R2020-08-10
00763000031251N/AMEDTRONIC PS MEDICAL, INC.484032020-07-20